<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04436744</url>
  </required_header>
  <id_info>
    <org_study_id>WO42133</org_study_id>
    <secondary_id>2020-001007-16</secondary_id>
    <nct_id>NCT04436744</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)</brief_title>
  <official_title>A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the&#xD;
      efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the&#xD;
      window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus&#xD;
      palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen&#xD;
      receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early&#xD;
      breast cancer.&#xD;
&#xD;
      The study consists of a screening period of up to 28 days, a window-of-opportunity phase for&#xD;
      14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles),&#xD;
      surgery, and an end of study visit (28 days after the final dose of study treatment).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Actual">November 24, 2021</completion_date>
  <primary_completion_date type="Actual">July 6, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative Percent Change in Ki67 Scores From Baseline to Week 2</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>Ki67 is a proliferation biomarker with prognostic value in ER-positive breast cancer. Ki67 scores were centrally assessed with immunohistochemistry and defined as a percentage of positively stained tumor cell nuclei among the total number of tumor cells assessed, with a potential range of 0-100%. A score of 0% indicates no tumor cell nuclei with Ki67 staining and a score of 100% indicates all tumor cell nuclei are positively stained with Ki67. The relative percentage change was calculated using Ki67 scores at Baseline and Week 2. Relative Percent Change was defined as Week 2 Ki67 percentage score/Baseline Ki67 percentage score*100. A smaller value of relative percentage change indicates improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) by Ultrasound as Determined by the Investigator</measure>
    <time_frame>Baseline up to Cycle 4 Day 1 (each cycle is 28 days)</time_frame>
    <description>ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by the investigator according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Ultrasound and clinical exam were used to assess response. CR per mRECIST was defined as the disappearance of all target lesions. PR per mRECIST was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. An estimate of ORR and its 95% confidence interval (CI) was calculated using the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Cell Cycle Arrest (CCCA) Rate at Week 2</measure>
    <time_frame>Week 2</time_frame>
    <description>CCCA was defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7%. The CCCA rate at Week 2 was summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) With Severity Determined in Accordance With National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)</measure>
    <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
    <description>AE is any untoward medical occurrence in clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable &amp; unintended sign, symptom/disease temporally associated with use of a medicinal product, whether or not related to medicinal product. Preexisting conditions which worsen during a study also considered as AEs. Severity of AEs was determined per NCI CTCAE v5.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Rate Over Time</measure>
    <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
    <description>Respiratory rate was measured while the participant was in a seated position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse Rate Over Time</measure>
    <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
    <description>Pulse rate was measured while the participant was in a seated position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure Over Time</measure>
    <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
    <description>Systolic blood pressure was measured while the participant was in a seated position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Diastolic Blood Pressure Over Time</measure>
    <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
    <description>Diastolic blood pressure was measured while the participant was in a seated position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Temperature Over Time</measure>
    <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Shifts in Hematology Test Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline</measure>
    <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
    <description>Hematology test parameters were measured per NCI CTCAE v5.0. Grade 0 is normal, and Grades 1 to 4 represent worsening levels of the parameter outside of the normal range in the specified direction of the abnormality (high and low are above and below the range, respectively). Number of participants with shift in the hematology values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. A marked reference range for hemoglobin 12.3-15.3 grams per deciliter (g/dL), lymphocytes absolute (Abs) 1.0-4.8 10^3/microliters (uL), neutrophils total, Abs, 1.8-8.5 10^3/uL, platelet 100-450 10^9/liter (L), total leukocyte 4.4-11 10^9/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Shifts in Blood Chemistry Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline</measure>
    <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
    <description>Blood chemistry parameters were measured per NCI CTCAE v5.0. Grade 0=normal, and Grades 1 to 4 represent worsening levels of parameter outside of normal range in the specified direction of abnormality (high &amp; low are above &amp; below the range, respectively). Number of participants with shift in blood chemistry values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. Marked reference range for albumin 32-45 grams per liter (g/L), alkaline phosphatase 20-130 units per liter (U/L), serum glutamic pyruvic transaminase (SGPT)/ alanine transaminase (ALT) 4-36 U/L, serum glutamic oxaloacetic transaminase (SGOT)/ aspartate transaminase (AST) 8-33 U/L, calcium 2.3-2.74 millimoles per liter (mmol/L), cholesterol 3.88-6.47mmol/L, creatinine 6-12 milligrams per liter (mg/L), glucose 3.9-6.1 mmol/L, potassium 3.5-5.0 mmol/L, sodium 135-147 mmol/L, bilirubin 2-21 micromoles per liter (μmol/L), triglycerides 0.11-2.15 mmol/L, &amp; uric acid 2.7-7.3 milligrams per deciliter (mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Giredestrant at Specified Timepoints</measure>
    <time_frame>Window of Opportunity Phase: Day 1 (3 hours Postdose) and Day 15 (Predose) during Cycle 0 (the 15-day period in Window of Opportunity Phase is called Cycle 0 for PK analysis); Neoadjuvant Phase: Cycle 2 Day 1, Predose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Early Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Giredestrant + Palbociclib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Anastrozole + Palbociclib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Giredestrant</intervention_name>
    <description>During the window-of-opportunity phase (first 2 weeks) giredestrant will be taken orally once per day (QD) as a single agent. During the neoadjuvant treatment phase, giredestrant will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.</description>
    <arm_group_label>Giredestrant + Palbociclib</arm_group_label>
    <other_name>GDC-9545</other_name>
    <other_name>RO7197597</other_name>
    <other_name>RG6171</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anastrozole</intervention_name>
    <description>During the window-of-opportunity phase (first 2 weeks), anastrozole 1 mg will be taken orally QD as a single agent. During the neoadjuvant treatment phase, anastrozole 1 mg will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.</description>
    <arm_group_label>Anastrozole + Palbociclib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>During the neoadjuvant treatment phase, palbociclib 125 mg will be taken orally QD on Days 1-21 of a 28-day cycle for a total of 4 cycles.</description>
    <arm_group_label>Anastrozole + Palbociclib</arm_group_label>
    <arm_group_label>Giredestrant + Palbociclib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Surgery must be performed within a maximum of 14 days after the final cycle in the neoadjuvant treatment phase and ideally should occur as soon as possible after the last dose of study treatment.</description>
    <arm_group_label>Anastrozole + Palbociclib</arm_group_label>
    <arm_group_label>Giredestrant + Palbociclib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women age ≥18 years&#xD;
&#xD;
          -  Histologically confirmed operable or inoperable invasive breast carcinoma&#xD;
&#xD;
          -  Candidate for neoadjuvant treatment and considered appropriate for endocrine therapy&#xD;
&#xD;
          -  Willingness to undergo breast surgery after neoadjuvant treatment and to provide three&#xD;
             mandatory tumor samples&#xD;
&#xD;
          -  Documented estrogen receptor (ER)-positive tumor in accordance to American Society of&#xD;
             Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et&#xD;
             al.2020), assessed locally and defined as ≥1% of tumor cells stained positive on the&#xD;
             basis of the most recent tumor biopsy&#xD;
&#xD;
          -  Documented progesterone receptor status (positive or negative) as per local assessment&#xD;
&#xD;
          -  Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in&#xD;
             accordance to 2018 ASCO/CAP guidelines (Wolff et al. 2018), assessed locally on the&#xD;
             most recent tumor biopsy&#xD;
&#xD;
          -  Ki67 score ≥5% analyzed centrally or locally&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group Performance Status 0-1&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stage IV (metastatic) breast cancer&#xD;
&#xD;
          -  Inflammatory breast cancer (cT4d)&#xD;
&#xD;
          -  Bilateral invasive breast cancer&#xD;
&#xD;
          -  History of invasive breast cancer, ductal carcinoma in situ or lobular carcinoma in&#xD;
             situ and other malignancy within 5 years prior to screening&#xD;
&#xD;
          -  Previous systemic or local treatment for the primary breast cancer currently under&#xD;
             investigation&#xD;
&#xD;
          -  History of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective&#xD;
             estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to randomization&#xD;
&#xD;
          -  Known clinically significant history of liver disease consistent with Child-Pugh Class&#xD;
             B or C, including hepatitis&#xD;
&#xD;
          -  Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the patient&#xD;
             inappropriate for entry into this study&#xD;
&#xD;
          -  History of allergy to anastrozole, or palbociclib or any of its excipients&#xD;
&#xD;
          -  Known issues with swallowing oral medication&#xD;
&#xD;
          -  History of documented hemorrhagic diathesis, coagulopathy, or thromboembolism&#xD;
&#xD;
          -  Active cardiac disease or history of cardiac dysfunction&#xD;
&#xD;
          -  Current treatment with medications that are well known to prolong the QT interval&#xD;
&#xD;
          -  Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major&#xD;
             upper gastrointestinal surgery including gastric resection&#xD;
&#xD;
          -  Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug&#xD;
             elimination half-lives prior to randomization&#xD;
&#xD;
          -  Known HIV infection&#xD;
&#xD;
          -  Serious infection requiring oral or IV antibiotics, or other clinically significant&#xD;
             infection within 14 days prior to screening&#xD;
&#xD;
          -  Any serious medical condition or abnormality in clinical laboratory tests that, in the&#xD;
             investigator's judgment, precludes the patient's safe participation in and completion&#xD;
             of the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA - Burbank</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA - Laguna Hills</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology-San Luis Obispo</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology Oncology-Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Memorial Physician Network/Cancer Care</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI Florida Cancer Specialists East</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Barnabas Medical Center Cancer Center</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology; Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Wisconsin-Madison; Clinical Science Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University Hospital</name>
      <address>
        <city>Macquarie Park</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital; Medical Oncology and Pallative Care</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Cancer de Pernambuco - HCP</name>
      <address>
        <city>Recife</city>
        <state>PE</state>
        <zip>50040-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01317-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04014-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LUISENKRANKENHAUS; Senological Oncology</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40235</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNIVERSITATSKLINIKUM ERLANGEN; Department of Gynecology and Obstetrics</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; Onkoradiologiai Kozpont</name>
      <address>
        <city>Kecskemet</city>
        <zip>6000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolna Megyei Kórház, Onkológia</name>
      <address>
        <city>Szekszárd</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center; Medical Oncology</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital; Internal Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>6591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Morski Im. Pck; Oncology &amp; Radiotherapy Dept</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DOLNOSLASKIE CENTRUM ONKOLOGII; Oddzial Chirurgii Piersi</name>
      <address>
        <city>Wrocław</city>
        <zip>53-413</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow City Oncology Hospital #62</name>
      <address>
        <city>Moscovskaya Oblast</city>
        <state>Moskovskaja Oblast</state>
        <zip>143423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Healthcare Institution Clinical Hospital RZhD Medicine</name>
      <address>
        <city>St. Petersburg</city>
        <state>Sankt Petersburg</state>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan</state>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603081</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSI &quot;SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutio Catalan De Oncologia</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Althaia; Servicio de Oncologia</name>
      <address>
        <city>Manresa</city>
        <state>Barcelona</state>
        <zip>08243</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Jerez de la Frontera; Servicio de Oncologia</name>
      <address>
        <city>Jerez de La Frontera</city>
        <state>Cadiz</state>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova</name>
      <address>
        <city>Lleida</city>
        <state>Lerida</state>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Sant Joan de Reus; Planta baja, color lila</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias;servicio de Oncologia</name>
      <address>
        <city>La Laguna</city>
        <state>Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quirón Dexeus</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves : Hospital General</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Cecilio</name>
      <address>
        <city>Granada</city>
        <zip>18016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>280146</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Jimenez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp Univ Fundacion Alcorcon</name>
      <address>
        <city>Madrid</city>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de La Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra; Servicio de Oncologia</name>
      <address>
        <city>Navarra</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung Uni Hospital; Surgery</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan Uni Hospital; General Surgery</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Oncology Center of Kharkiv Regional Council; Department of Soft Tissues and Breast Cancer</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkiv Governorate</state>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odesa Regional Clinical Hospital; Department of Thoracic Surgery</name>
      <address>
        <city>Odesa</city>
        <state>Kharkiv Governorate</state>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khmelnytsky Regional Antitumor Center; Department of Breast, Skin, Soft Tissues and Bones Tumors</name>
      <address>
        <city>Khmelnytskyi</city>
        <state>Podolia Governorate</state>
        <zip>29009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal institution Dnipropetrovsk City Multifield Clinical Hospital #4; dept. of Chemotherapy</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department</name>
      <address>
        <city>Kryvyi Rih</city>
        <zip>50048</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Regional Oncological Dispensary</name>
      <address>
        <city>Kyiv</city>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <results_first_submitted>November 21, 2022</results_first_submitted>
  <results_first_submitted_qc>January 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 2, 2023</results_first_posted>
  <disposition_first_submitted>June 23, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>January 9, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 2, 2023</disposition_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Palbociclib</mesh_term>
    <mesh_term>Anastrozole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).&#xD;
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04436744/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in this study at 64 investigative sites in Australia, Brazil, Germany, Hungary, Korea, Poland, Russia, Spain, Taiwan, the United States, and Ukraine, from 4 September 2020 to 24 November 2021.</recruitment_details>
      <pre_assignment_details>A total of 264 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Giredestrant + Palbociclib</title>
          <description>Participants received giredestrant, 30 milligrams (mg), orally, once per day (QD), during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
        </group>
        <group group_id="P2">
          <title>Anastrozole + Palbociclib</title>
          <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-Treat (ITT) population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Giredestrant + Palbociclib</title>
          <description>Participants received giredestrant, 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
        </group>
        <group group_id="B2">
          <title>Anastrozole + Palbociclib</title>
          <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="112"/>
            <count group_id="B2" value="109"/>
            <count group_id="B3" value="221"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.1" spread="7.9"/>
                    <measurement group_id="B2" value="62.4" spread="9.3"/>
                    <measurement group_id="B3" value="62.8" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ki67 Scores</title>
          <description>Ki67 is a proliferation biomarker with prognostic value in estrogen receptor (ER)-positive breast cancer. Ki67 scores were centrally assessed with immunohistochemistry and defined as a percentage of positively stained tumor cell nuclei among the total number of tumor cells assessed, with a potential range of 0-100%. A score of 0% indicates no tumor cell nuclei with Ki67 staining and a score of 100% indicates all tumor cell nuclei are positively stained with Ki67. The higher percentage score indicates higher risk of recurrence.</description>
          <units>percent Ki67 score</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.92" lower_limit="6.6" upper_limit="96.3"/>
                    <measurement group_id="B2" value="41.66" lower_limit="7.8" upper_limit="98.9"/>
                    <measurement group_id="B3" value="39.76" lower_limit="6.6" upper_limit="98.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Relative Percent Change in Ki67 Scores From Baseline to Week 2</title>
        <description>Ki67 is a proliferation biomarker with prognostic value in ER-positive breast cancer. Ki67 scores were centrally assessed with immunohistochemistry and defined as a percentage of positively stained tumor cell nuclei among the total number of tumor cells assessed, with a potential range of 0-100%. A score of 0% indicates no tumor cell nuclei with Ki67 staining and a score of 100% indicates all tumor cell nuclei are positively stained with Ki67. The relative percentage change was calculated using Ki67 scores at Baseline and Week 2. Relative Percent Change was defined as Week 2 Ki67 percentage score/Baseline Ki67 percentage score*100. A smaller value of relative percentage change indicates improvement.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>Efficacy-evaluable population included participants with Ki67-evaluable tumor specimens at baseline and Week 2. Participants with missing central Ki67 scores at baseline and/or Week 2 were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant, 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Percent Change in Ki67 Scores From Baseline to Week 2</title>
          <description>Ki67 is a proliferation biomarker with prognostic value in ER-positive breast cancer. Ki67 scores were centrally assessed with immunohistochemistry and defined as a percentage of positively stained tumor cell nuclei among the total number of tumor cells assessed, with a potential range of 0-100%. A score of 0% indicates no tumor cell nuclei with Ki67 staining and a score of 100% indicates all tumor cell nuclei are positively stained with Ki67. The relative percentage change was calculated using Ki67 scores at Baseline and Week 2. Relative Percent Change was defined as Week 2 Ki67 percentage score/Baseline Ki67 percentage score*100. A smaller value of relative percentage change indicates improvement.</description>
          <population>Efficacy-evaluable population included participants with Ki67-evaluable tumor specimens at baseline and Week 2. Participants with missing central Ki67 scores at baseline and/or Week 2 were excluded from the analysis.</population>
          <units>percent change</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" lower_limit="20" upper_limit="30"/>
                    <measurement group_id="O2" value="33" lower_limit="27" upper_limit="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0433</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR) by Ultrasound as Determined by the Investigator</title>
        <description>ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by the investigator according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Ultrasound and clinical exam were used to assess response. CR per mRECIST was defined as the disappearance of all target lesions. PR per mRECIST was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. An estimate of ORR and its 95% confidence interval (CI) was calculated using the Clopper-Pearson method.</description>
        <time_frame>Baseline up to Cycle 4 Day 1 (each cycle is 28 days)</time_frame>
        <population>ORR-evaluable population included all randomized participants with measurable disease at baseline. Participants not meeting the criteria for ORR, including participants without any post-baseline tumor assessment, were considered as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant, 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) by Ultrasound as Determined by the Investigator</title>
          <description>ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by the investigator according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Ultrasound and clinical exam were used to assess response. CR per mRECIST was defined as the disappearance of all target lesions. PR per mRECIST was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. An estimate of ORR and its 95% confidence interval (CI) was calculated using the Clopper-Pearson method.</description>
          <population>ORR-evaluable population included all randomized participants with measurable disease at baseline. Participants not meeting the criteria for ORR, including participants without any post-baseline tumor assessment, were considered as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="40.40" upper_limit="59.60"/>
                    <measurement group_id="O2" value="49.1" lower_limit="39.33" upper_limit="58.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>ORR was calculated using the stratified Cochran-Mantel-Haenszel test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8272</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Overall Response Rates</param_type>
            <param_value>-0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.66</ci_lower_limit>
            <ci_upper_limit>12.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Cell Cycle Arrest (CCCA) Rate at Week 2</title>
        <description>CCCA was defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7%. The CCCA rate at Week 2 was summarized.</description>
        <time_frame>Week 2</time_frame>
        <population>Efficacy-evaluable population included participants with Ki67-evaluable tumor specimens at baseline and Week 2. Participants with missing central Ki67 scores at baseline and/or Week 2 were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant, 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Cell Cycle Arrest (CCCA) Rate at Week 2</title>
          <description>CCCA was defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7%. The CCCA rate at Week 2 was summarized.</description>
          <population>Efficacy-evaluable population included participants with Ki67-evaluable tumor specimens at baseline and Week 2. Participants with missing central Ki67 scores at baseline and/or Week 2 were excluded from the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6"/>
                    <measurement group_id="O2" value="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Rate</param_type>
            <param_value>6.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.25</ci_lower_limit>
            <ci_upper_limit>17.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) With Severity Determined in Accordance With National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)</title>
        <description>AE is any untoward medical occurrence in clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable &amp; unintended sign, symptom/disease temporally associated with use of a medicinal product, whether or not related to medicinal product. Preexisting conditions which worsen during a study also considered as AEs. Severity of AEs was determined per NCI CTCAE v5.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.</description>
        <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant, 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) With Severity Determined in Accordance With National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)</title>
          <description>AE is any untoward medical occurrence in clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable &amp; unintended sign, symptom/disease temporally associated with use of a medicinal product, whether or not related to medicinal product. Preexisting conditions which worsen during a study also considered as AEs. Severity of AEs was determined per NCI CTCAE v5.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Rate Over Time</title>
        <description>Respiratory rate was measured while the participant was in a seated position.</description>
        <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Rate Over Time</title>
          <description>Respiratory rate was measured while the participant was in a seated position.</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>breath/minute (min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.16" spread="2.27"/>
                    <measurement group_id="O2" value="17.10" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="2.12"/>
                    <measurement group_id="O2" value="0.26" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="1.49"/>
                    <measurement group_id="O2" value="-0.06" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="1.83"/>
                    <measurement group_id="O2" value="0.16" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="1.71"/>
                    <measurement group_id="O2" value="-0.03" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.58"/>
                    <measurement group_id="O2" value="0.01" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="1.71"/>
                    <measurement group_id="O2" value="0.01" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="1.72"/>
                    <measurement group_id="O2" value="-0.02" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="1.65"/>
                    <measurement group_id="O2" value="0.01" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse Rate Over Time</title>
        <description>Pulse rate was measured while the participant was in a seated position.</description>
        <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate Over Time</title>
          <description>Pulse rate was measured while the participant was in a seated position.</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.86" spread="10.67"/>
                    <measurement group_id="O2" value="76.73" spread="9.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.74" spread="9.07"/>
                    <measurement group_id="O2" value="-1.96" spread="9.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.02" spread="12.02"/>
                    <measurement group_id="O2" value="-1.47" spread="8.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.20" spread="10.26"/>
                    <measurement group_id="O2" value="-1.11" spread="10.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.68" spread="11.03"/>
                    <measurement group_id="O2" value="-1.95" spread="8.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.47" spread="11.61"/>
                    <measurement group_id="O2" value="-0.81" spread="10.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.67" spread="9.79"/>
                    <measurement group_id="O2" value="-1.11" spread="10.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.14" spread="11.25"/>
                    <measurement group_id="O2" value="-1.26" spread="10.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.61" spread="10.74"/>
                    <measurement group_id="O2" value="1.59" spread="10.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure Over Time</title>
        <description>Systolic blood pressure was measured while the participant was in a seated position.</description>
        <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure Over Time</title>
          <description>Systolic blood pressure was measured while the participant was in a seated position.</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.63" spread="14.13"/>
                    <measurement group_id="O2" value="130.03" spread="16.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.82" spread="11.11"/>
                    <measurement group_id="O2" value="1.12" spread="13.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.55" spread="14.01"/>
                    <measurement group_id="O2" value="0.23" spread="15.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="14.13"/>
                    <measurement group_id="O2" value="0.28" spread="14.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.25" spread="15.37"/>
                    <measurement group_id="O2" value="0.16" spread="16.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.66" spread="16.95"/>
                    <measurement group_id="O2" value="0.33" spread="15.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="15.30"/>
                    <measurement group_id="O2" value="-0.25" spread="14.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.35" spread="13.79"/>
                    <measurement group_id="O2" value="1.51" spread="15.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.38" spread="13.98"/>
                    <measurement group_id="O2" value="-1.67" spread="16.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Diastolic Blood Pressure Over Time</title>
        <description>Diastolic blood pressure was measured while the participant was in a seated position.</description>
        <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diastolic Blood Pressure Over Time</title>
          <description>Diastolic blood pressure was measured while the participant was in a seated position.</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.40" spread="8.84"/>
                    <measurement group_id="O2" value="78.49" spread="9.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" spread="7.77"/>
                    <measurement group_id="O2" value="0.39" spread="8.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.80" spread="8.58"/>
                    <measurement group_id="O2" value="-2.42" spread="8.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.79" spread="10.08"/>
                    <measurement group_id="O2" value="-0.76" spread="8.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.64" spread="9.24"/>
                    <measurement group_id="O2" value="-1.32" spread="9.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.25" spread="8.51"/>
                    <measurement group_id="O2" value="-0.16" spread="9.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.35" spread="9.31"/>
                    <measurement group_id="O2" value="-2.57" spread="9.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.93" spread="8.72"/>
                    <measurement group_id="O2" value="-2.15" spread="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.73" spread="8.37"/>
                    <measurement group_id="O2" value="-2.52" spread="12.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Temperature Over Time</title>
        <time_frame>Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Temperature Over Time</title>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>Celsius (C)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.35" spread="0.41"/>
                    <measurement group_id="O2" value="36.45" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.39"/>
                    <measurement group_id="O2" value="0.04" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.41"/>
                    <measurement group_id="O2" value="-0.01" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.40"/>
                    <measurement group_id="O2" value="-0.04" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 2 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.37"/>
                    <measurement group_id="O2" value="-0.12" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.42"/>
                    <measurement group_id="O2" value="0.01" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.37"/>
                    <measurement group_id="O2" value="-0.08" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day of Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.39"/>
                    <measurement group_id="O2" value="-0.01" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.39"/>
                    <measurement group_id="O2" value="-0.04" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Shifts in Hematology Test Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline</title>
        <description>Hematology test parameters were measured per NCI CTCAE v5.0. Grade 0 is normal, and Grades 1 to 4 represent worsening levels of the parameter outside of the normal range in the specified direction of the abnormality (high and low are above and below the range, respectively). Number of participants with shift in the hematology values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. A marked reference range for hemoglobin 12.3-15.3 grams per deciliter (g/dL), lymphocytes absolute (Abs) 1.0-4.8 10^3/microliters (uL), neutrophils total, Abs, 1.8-8.5 10^3/uL, platelet 100-450 10^9/liter (L), total leukocyte 4.4-11 10^9/L.</description>
        <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Participants with at least 1 post-baseline assessment were included in the analysis. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Shifts in Hematology Test Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline</title>
          <description>Hematology test parameters were measured per NCI CTCAE v5.0. Grade 0 is normal, and Grades 1 to 4 represent worsening levels of the parameter outside of the normal range in the specified direction of the abnormality (high and low are above and below the range, respectively). Number of participants with shift in the hematology values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. A marked reference range for hemoglobin 12.3-15.3 grams per deciliter (g/dL), lymphocytes absolute (Abs) 1.0-4.8 10^3/microliters (uL), neutrophils total, Abs, 1.8-8.5 10^3/uL, platelet 100-450 10^9/liter (L), total leukocyte 4.4-11 10^9/L.</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Participants with at least 1 post-baseline assessment were included in the analysis. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes Abs: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes Abs: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Total, Abs: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Leukocyte Count: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Leukocyte Count: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Shifts in Blood Chemistry Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline</title>
        <description>Blood chemistry parameters were measured per NCI CTCAE v5.0. Grade 0=normal, and Grades 1 to 4 represent worsening levels of parameter outside of normal range in the specified direction of abnormality (high &amp; low are above &amp; below the range, respectively). Number of participants with shift in blood chemistry values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. Marked reference range for albumin 32-45 grams per liter (g/L), alkaline phosphatase 20-130 units per liter (U/L), serum glutamic pyruvic transaminase (SGPT)/ alanine transaminase (ALT) 4-36 U/L, serum glutamic oxaloacetic transaminase (SGOT)/ aspartate transaminase (AST) 8-33 U/L, calcium 2.3-2.74 millimoles per liter (mmol/L), cholesterol 3.88-6.47mmol/L, creatinine 6-12 milligrams per liter (mg/L), glucose 3.9-6.1 mmol/L, potassium 3.5-5.0 mmol/L, sodium 135-147 mmol/L, bilirubin 2-21 micromoles per liter (μmol/L), triglycerides 0.11-2.15 mmol/L, &amp; uric acid 2.7-7.3 milligrams per deciliter (mg/dL).</description>
        <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
        <population>Safety-evaluable population included all participants who received any amount of study treatment. Participants with at least 1 post-baseline assessment were included in the analysis. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Anastrozole + Palbociclib</title>
            <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Shifts in Blood Chemistry Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline</title>
          <description>Blood chemistry parameters were measured per NCI CTCAE v5.0. Grade 0=normal, and Grades 1 to 4 represent worsening levels of parameter outside of normal range in the specified direction of abnormality (high &amp; low are above &amp; below the range, respectively). Number of participants with shift in blood chemistry values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. Marked reference range for albumin 32-45 grams per liter (g/L), alkaline phosphatase 20-130 units per liter (U/L), serum glutamic pyruvic transaminase (SGPT)/ alanine transaminase (ALT) 4-36 U/L, serum glutamic oxaloacetic transaminase (SGOT)/ aspartate transaminase (AST) 8-33 U/L, calcium 2.3-2.74 millimoles per liter (mmol/L), cholesterol 3.88-6.47mmol/L, creatinine 6-12 milligrams per liter (mg/L), glucose 3.9-6.1 mmol/L, potassium 3.5-5.0 mmol/L, sodium 135-147 mmol/L, bilirubin 2-21 micromoles per liter (μmol/L), triglycerides 0.11-2.15 mmol/L, &amp; uric acid 2.7-7.3 milligrams per deciliter (mg/dL).</description>
          <population>Safety-evaluable population included all participants who received any amount of study treatment. Participants with at least 1 post-baseline assessment were included in the analysis. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin: low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SGPT/ALT: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SGOT/AST: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid: High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Giredestrant at Specified Timepoints</title>
        <time_frame>Window of Opportunity Phase: Day 1 (3 hours Postdose) and Day 15 (Predose) during Cycle 0 (the 15-day period in Window of Opportunity Phase is called Cycle 0 for PK analysis); Neoadjuvant Phase: Cycle 2 Day 1, Predose</time_frame>
        <population>Pharmacokinetics (PK) evaluable population included all participants who received giredestrant and had at least one evaluable post-dose giredestrant plasma concentration. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Giredestrant + Palbociclib</title>
            <description>Participants received giredestrant 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Giredestrant at Specified Timepoints</title>
          <population>Pharmacokinetics (PK) evaluable population included all participants who received giredestrant and had at least one evaluable post-dose giredestrant plasma concentration. Number analyzed is the number of participants with data available for analysis at the specified time point.</population>
          <units>nanograms per milliliters (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Window of Opportunity Phase: Cycle 0 Day 1, 3-h Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8" spread="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Window of Opportunity Phase: Cycle 0 Day 15, Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137" spread="61.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neoadjuvant Phase: Cycle 2 Day 1, Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130" spread="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 28 days after the last dose (up to approximately 24 weeks)</time_frame>
      <desc>AEs are reported for the safety-evaluable population that was defined as all participants who received any amount of study treatment, grouped according to treatment received. All-cause mortality was also reported for the safety-evaluable population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Giredestrant + Palbociclib</title>
          <description>Participants received giredestrant, 30 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received giredestrant, 30 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
        </group>
        <group group_id="E2">
          <title>Anastrozole + Palbociclib</title>
          <description>Participants received anastrozole, 1 mg, orally, QD, during the window-of-opportunity phase of two weeks. During the neoadjuvant treatment phase, participants received anastrozole, 1 mg, orally, QD on Days 1-28 of each 28-day cycle for a total of 4 cycles in combination with palbociclib, 125 mg, administered orally, QD on Days 1-21 of each 28-day cycle for a total of 4 cycles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Uterine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="99" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="93" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="112"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="14" subjects_at_risk="112"/>
                <counts group_id="E2" events="29" subjects_affected="16" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="77" subjects_affected="46" subjects_at_risk="112"/>
                <counts group_id="E2" events="79" subjects_affected="44" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="112"/>
                <counts group_id="E2" events="25" subjects_affected="18" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="112"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="25" subjects_at_risk="112"/>
                <counts group_id="E2" events="31" subjects_affected="27" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="112"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="112"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="39" subjects_affected="26" subjects_at_risk="112"/>
                <counts group_id="E2" events="32" subjects_affected="24" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="14" subjects_at_risk="112"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="112"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="112"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="112"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="112"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04436744
org study id: WO42133
secondary id: 2020-001007-16
nct id: NCT04436744
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the
      efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the
      window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus
      palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen
      receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early
      breast cancer.

      The study consists of a screening period of up to 28 days, a window-of-opportunity phase for
      14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles),
      surgery, and an end of study visit (28 days after the final dose of study treatment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relative Percent Change in Ki67 Scores From Baseline to Week 2
time frame: Baseline, Week 2
description: Ki67 is a proliferation biomarker with prognostic value in ER-positive breast cancer. Ki67 scores were centrally assessed with immunohistochemistry and defined as a percentage of positively stained tumor cell nuclei among the total number of tumor cells assessed, with a potential range of 0-100%. A score of 0% indicates no tumor cell nuclei with Ki67 staining and a score of 100% indicates all tumor cell nuclei are positively stained with Ki67. The relative percentage change was calculated using Ki67 scores at Baseline and Week 2. Relative Percent Change was defined as Week 2 Ki67 percentage score/Baseline Ki67 percentage score*100. A smaller value of relative percentage change indicates improvement.
measure: Overall Response Rate (ORR) by Ultrasound as Determined by the Investigator
time frame: Baseline up to Cycle 4 Day 1 (each cycle is 28 days)
description: ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by the investigator according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Ultrasound and clinical exam were used to assess response. CR per mRECIST was defined as the disappearance of all target lesions. PR per mRECIST was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. An estimate of ORR and its 95% confidence interval (CI) was calculated using the Clopper-Pearson method.
measure: Complete Cell Cycle Arrest (CCCA) Rate at Week 2
time frame: Week 2
description: CCCA was defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7%. The CCCA rate at Week 2 was summarized.
measure: Number of Participants With Adverse Events (AEs) With Severity Determined in Accordance With National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
time frame: From baseline up to 28 days after the last dose (up to approximately 24 weeks)
description: AE is any untoward medical occurrence in clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable & unintended sign, symptom/disease temporally associated with use of a medicinal product, whether or not related to medicinal product. Preexisting conditions which worsen during a study also considered as AEs. Severity of AEs was determined per NCI CTCAE v5.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.
measure: Change From Baseline in Respiratory Rate Over Time
time frame: Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
description: Respiratory rate was measured while the participant was in a seated position.
measure: Change From Baseline in Pulse Rate Over Time
time frame: Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
description: Pulse rate was measured while the participant was in a seated position.
measure: Change From Baseline in Systolic Blood Pressure Over Time
time frame: Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
description: Systolic blood pressure was measured while the participant was in a seated position.
measure: Change From Baseline in Diastolic Blood Pressure Over Time
time frame: Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
description: Diastolic blood pressure was measured while the participant was in a seated position.
measure: Change From Baseline in Body Temperature Over Time
time frame: Baseline; Cycles 1-2: Day 1 and Day 15; Cycles 3-4: Day 1; day of surgery (up to 2 weeks after the final dose of study treatment [approximately Week 18]) and end of study (up to approximately 24 weeks)
measure: Number of Participants With Shifts in Hematology Test Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline
time frame: From baseline up to 28 days after the last dose (up to approximately 24 weeks)
description: Hematology test parameters were measured per NCI CTCAE v5.0. Grade 0 is normal, and Grades 1 to 4 represent worsening levels of the parameter outside of the normal range in the specified direction of the abnormality (high and low are above and below the range, respectively). Number of participants with shift in the hematology values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. A marked reference range for hemoglobin 12.3-15.3 grams per deciliter (g/dL), lymphocytes absolute (Abs) 1.0-4.8 10^3/microliters (uL), neutrophils total, Abs, 1.8-8.5 10^3/uL, platelet 100-450 10^9/liter (L), total leukocyte 4.4-11 10^9/L.
measure: Number of Participants With Shifts in Blood Chemistry Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline
time frame: From baseline up to 28 days after the last dose (up to approximately 24 weeks)
description: Blood chemistry parameters were measured per NCI CTCAE v5.0. Grade 0=normal, and Grades 1 to 4 represent worsening levels of parameter outside of normal range in the specified direction of abnormality (high & low are above & below the range, respectively). Number of participants with shift in blood chemistry values from grade 0-2 at baseline to grade 3-4 at post-baseline were reported. Marked reference range for albumin 32-45 grams per liter (g/L), alkaline phosphatase 20-130 units per liter (U/L), serum glutamic pyruvic transaminase (SGPT)/ alanine transaminase (ALT) 4-36 U/L, serum glutamic oxaloacetic transaminase (SGOT)/ aspartate transaminase (AST) 8-33 U/L, calcium 2.3-2.74 millimoles per liter (mmol/L), cholesterol 3.88-6.47mmol/L, creatinine 6-12 milligrams per liter (mg/L), glucose 3.9-6.1 mmol/L, potassium 3.5-5.0 mmol/L, sodium 135-147 mmol/L, bilirubin 2-21 micromoles per liter (μmol/L), triglycerides 0.11-2.15 mmol/L, & uric acid 2.7-7.3 milligrams per deciliter (mg/dL).
measure: Plasma Concentration of Giredestrant at Specified Timepoints
time frame: Window of Opportunity Phase: Day 1 (3 hours Postdose) and Day 15 (Predose) during Cycle 0 (the 15-day period in Window of Opportunity Phase is called Cycle 0 for PK analysis); Neoadjuvant Phase: Cycle 2 Day 1, Predose
arm group label: Giredestrant + Palbociclib
arm group type: Experimental
arm group label: Anastrozole + Palbociclib
arm group type: Active Comparator
intervention type: Drug
intervention name: Giredestrant
description: During the window-of-opportunity phase (first 2 weeks) giredestrant will be taken orally once per day (QD) as a single agent. During the neoadjuvant treatment phase, giredestrant will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.
arm group label: Giredestrant + Palbociclib
other name: GDC-9545
other name: RO7197597
other name: RG6171
intervention type: Drug
intervention name: Anastrozole
description: During the window-of-opportunity phase (first 2 weeks), anastrozole 1 mg will be taken orally QD as a single agent. During the neoadjuvant treatment phase, anastrozole 1 mg will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.
arm group label: Anastrozole + Palbociclib
intervention type: Drug
intervention name: Palbociclib
description: During the neoadjuvant treatment phase, palbociclib 125 mg will be taken orally QD on Days 1-21 of a 28-day cycle for a total of 4 cycles.
arm group label: Anastrozole + Palbociclib
arm group label: Giredestrant + Palbociclib
intervention type: Procedure
intervention name: Surgery
description: Surgery must be performed within a maximum of 14 days after the final cycle in the neoadjuvant treatment phase and ideally should occur as soon as possible after the last dose of study treatment.
arm group label: Anastrozole + Palbociclib
arm group label: Giredestrant + Palbociclib
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Brazil
country: Germany
country: Hungary
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Palbociclib
mesh term: Anastrozole
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 