<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/NCT01709370</url>
  </required_header>
  <id_info>
    <org_study_id>OOTR-N007/LET-CDK</org_study_id>
    <nct_id>NCT01709370</nct_id>
  </id_info>
  <brief_title>Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women</brief_title>
  <official_title>Phase II Neoadjuvant Study of Letrozole in Combination With PD0332991 (Oral CDK 4/6 Inhibitor) for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organisation for Oncology and Translational Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Organisation for Oncology and Translational Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase II study evaluating the efficacy and safety of the pre-operative use of&#xD;
      letrozole plus PD 0332991 (combination therapy)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rates</measure>
    <time_frame>Every 4 weeks before surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Continuous during the study, up to 28 days after the last treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pathologic response rates</measure>
    <time_frame>At time of definitive surgery</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>ER Positive, HER2 Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Letrozole plus PD 0332991</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Letrozole 2.5mg/d for 16 weeks before surgery plus PD 0332991 (CDK-4/6 inhibitor) 125 mg/d for 3 out of 4 weeks in repeated cycles for 16 weeks before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Letrozole, PD 0332991</intervention_name>
    <arm_group_label>Letrozole plus PD 0332991</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women&#xD;
&#xD;
          -  Primary tumor greater than 2 cm in diameter&#xD;
&#xD;
          -  Histologically proven invasive breast cancer&#xD;
&#xD;
          -  Positive estrogen receptor&#xD;
&#xD;
          -  Negative HER-2 receptor&#xD;
&#xD;
          -  ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%&#xD;
&#xD;
          -  Laboratory values must be follows:&#xD;
&#xD;
        Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL;&#xD;
        Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); Serum Creatinine ≤ 1.5 × ULN;&#xD;
        Alkaline phosphatase ≤ 2 × ULN; AST and ALT ≤ 2 × ULN; Normal finding of ECG - QTc ≤ 470&#xD;
        msec (based on the mean value of the triplicate ECGs); Left ventricular ejection fraction&#xD;
        (LVEF) ≥ 60%.&#xD;
&#xD;
          -  Able to give written informed consent form&#xD;
&#xD;
          -  Able to follow prescription instructions reasonably well&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Severe psychiatric disorder&#xD;
&#xD;
          -  Prior history of other malignancy within 5 years of study entry, aside from basal cell&#xD;
             carcinoma or the skin or carcinoma-in-situ of the uterine cervix&#xD;
&#xD;
          -  Locally advanced breast cancer (T3N1 or Any T4 or Any N2, N3), or distant metastasis&#xD;
&#xD;
          -  Multifocal or multicentric breast cancer except that the largest lesion is greater&#xD;
             than 2cm&#xD;
&#xD;
          -  Major surgery within 3 weeks of first study treatment&#xD;
&#xD;
          -  Current use or anticipated need for:&#xD;
&#xD;
        Food or drugs that are known strong CYP3A4 inhibitors; drugs that are known strong CYP3A4&#xD;
        inducers&#xD;
&#xD;
          -  Severe cardiovascular diseases in the previous 6 months&#xD;
&#xD;
          -  Active inflammatory bowel disease or chronic diarrhea&#xD;
&#xD;
          -  Renal Impairment&#xD;
&#xD;
          -  Poor adrenal function&#xD;
&#xD;
          -  Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function)&#xD;
&#xD;
          -  Known human immunodeficiency virus infection&#xD;
&#xD;
          -  Known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor&#xD;
&#xD;
          -  Other severe acute or chronic medical or psychiatric condition, or laboratory&#xD;
             abnormality that would impart, in the judgment of the investigator, excess risk&#xD;
             associated with study participation or study drug administration, or which, in the&#xD;
             judgment of the investigator, would make the patient inappropriate for entry into this&#xD;
             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_contact>
    <last_name>Louis Chow, MD</last_name>
    <phone>(852)28610286</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Unimed Medical Institute</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louis Chow, MD</last_name>
      <phone>(852)28610286</phone>
    </contact>
    <investigator>
      <last_name>Louis Chow, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>December 29, 2013</last_update_submitted>
  <last_update_submitted_qc>December 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2013</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>Letrozole</mesh_term>
    <mesh_term>Palbociclib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01709370
org study id: OOTR-N007/LET-CDK
nct id: NCT01709370
lead sponsor: 
has dmc: Yes
This is a phase II study evaluating the efficacy and safety of the pre-operative use of
      letrozole plus PD 0332991 (combination therapy)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rates
time frame: Every 4 weeks before surgery
measure: Number of Participants with Adverse Events
time frame: Continuous during the study, up to 28 days after the last treatment
measure: Pathologic response rates
time frame: At time of definitive surgery
arm group label: Letrozole plus PD 0332991
arm group type: Experimental
description: Drug: Letrozole 2.5mg/d for 16 weeks before surgery plus PD 0332991 (CDK-4/6 inhibitor) 125 mg/d for 3 out of 4 weeks in repeated cycles for 16 weeks before surgery
intervention type: Drug
intervention name: Letrozole, PD 0332991
arm group label: Letrozole plus PD 0332991
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Louis Chow, MD
phone: (852)28610286
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Letrozole
mesh term: Palbociclib