<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/NCT04425018</url>
  </required_header>
  <id_info>
    <org_study_id>20-068</org_study_id>
    <nct_id>NCT04425018</nct_id>
  </id_info>
  <brief_title>MARGetuximab Or Trastuzumab (MARGOT)</brief_title>
  <acronym>MARGOT</acronym>
  <official_title>MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MacroGenics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Translational Breast Cancer Research Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to determine how well participants with stage II-III&#xD;
      HER2-positive breast cancer respond to pre-operative treatment using one of two different&#xD;
      combinations of drugs.&#xD;
&#xD;
      Drugs and Combinations used:&#xD;
&#xD;
        -  Paclitaxel, Pertzumab and Margetuximab (Margenza)&#xD;
&#xD;
        -  Paclitaxel, Pertzumab and Trastuzumab (Herceptin)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab&#xD;
      (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2&#xD;
      positive breast cancer.&#xD;
&#xD;
        -  The research study procedures include screening for eligibility and study treatment&#xD;
           including laboratory evaluations, two mandatory research biopsies and follow up visits.&#xD;
&#xD;
        -  Participants will be randomized, which means randomly assigned, to one of two treatment&#xD;
           arms. The treatment arms in this study and the names of the study drugs in each arm are:&#xD;
&#xD;
             -  Arm A: Paclitaxel, Pertzumab and Margetuximab&#xD;
&#xD;
             -  Arm B: Paclitaxel, Pertzumab and Trastuzumab&#xD;
&#xD;
      Participants will receive study treatment for 12 weeks prior to surgery and will be followed&#xD;
      for 10 years after surgery. After surgery, some participants will continue to receive the&#xD;
      study drug margetuximab for a year in total, if they respond very well to the first 12 weeks&#xD;
      of treatment with margetuximab.&#xD;
&#xD;
      It is expected that about 171 people will take part in this research study.&#xD;
&#xD;
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety&#xD;
      and effectiveness of an investigational drug combination to learn whether the drug&#xD;
      combination works in treating a specific disease. &quot;Investigational&quot; means that the drug&#xD;
      combination is being studied.&#xD;
&#xD;
      The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab&#xD;
      (Herceptin), and pertuzumab as part of a pre-operative treatment option for stage II-III&#xD;
      HER2-positive breast cancer.&#xD;
&#xD;
      The U.S. Food and Drug Administration (FDA) has approved margetuximab (Margenza) for advanced&#xD;
      HER2-positive breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</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>Rate of pathologic complete response (pCR)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Compare rate of pathologic complete response (pCR, defined as RCB 0) in patients with the FF or FV CD16A genotype and anatomic stage II-III HER2+ breast cancer treated with 4 cycles of neoadjuvant TMP or THP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of pathologic complete response</measure>
    <time_frame>12 weeks</time_frame>
    <description>Compare rate of pCR (RCB 0) in patients treated with TMP or THP, according to hormone receptor-positive (HR+) or hormone receptor-negative (HR-) status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Cancer Burden (RCB) scores</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assess Residual Cancer Burden (RCB) scores1 in patients treated with TMP or THP, overall and according to HR+ or HR- status. reported using the Residual Cancer Burden calculator from M.D Anderson:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic response rate</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Assess radiographic response to neoadjuvant therapy in patients treated with TMP or&#xD;
THP, overall and according to HR+ or HR- status.Response criteria are based on the RECIST 1.1 criteria:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Treatment Related Adverse Events according to CTCAE v5.0</measure>
    <time_frame>From first treatment to 12 weeks</time_frame>
    <description>Assessment of DLTs on Arm A during the first 21 days of treatment Maximum grade of all treatment-related adverse events according to CTCAE v5.0 Patient-reported outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS)</measure>
    <time_frame>From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS) Patients with RCB 0 or 1</measure>
    <time_frame>From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS)Patients with RCB 2 or 3</measure>
    <time_frame>From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS) Patients randomized to neoadjuvant TMP</measure>
    <time_frame>From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS) patients randomized to neoadjuvant THP</measure>
    <time_frame>From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS) -Patients with pCR</measure>
    <time_frame>From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival rate (EFS) -Patients without pCR</measure>
    <time_frame>From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI)</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI) RCB 0 or 1</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI) RCB 2 or 3</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI) Patients randomized to neoadjuvant TMP</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI) Patients randomized to neoadjuvant THP</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI) Patients with pCR</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence ror death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free interval rate (RFI) Patients without pCR</measure>
    <time_frame>patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS)</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS) Patients with RCB 0 or 1</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS) Patients with RCB 2 or 3</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS) Patients randomized to neoadjuvant TMP</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS) randomized to neoadjuvant THP</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS) Patients with pCR</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival Rate (OS) Patients without CR</measure>
    <time_frame>up to 10 years from definitive surgery.</time_frame>
    <description>The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">171</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage III Breast Cancer</condition>
  <condition>HER2-positive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Paclitaxel + Pertuzumab + Margetuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days&#xD;
Paclitaxel- via IV, Day 1,8,15 of each cycle&#xD;
Margetuximab via IV, Day 1 of each cycle&#xD;
Pertuzumab via IV, Day 1 of each cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel + Pertuzumab + Trastuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days&#xD;
Paclitaxel- via IV, Day 1,8,15 of each cycle&#xD;
Pertuzumab via IV, Day 1 of each cycle&#xD;
Trastuzumab via IV, Day 1 of each cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.</description>
    <arm_group_label>Paclitaxel + Pertuzumab + Margetuximab</arm_group_label>
    <arm_group_label>Paclitaxel + Pertuzumab + Trastuzumab</arm_group_label>
    <other_name>Taxol</other_name>
    <other_name>Onxal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pertuzumab</intervention_name>
    <description>Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.</description>
    <arm_group_label>Paclitaxel + Pertuzumab + Margetuximab</arm_group_label>
    <arm_group_label>Paclitaxel + Pertuzumab + Trastuzumab</arm_group_label>
    <other_name>Perjeta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Margetuximab</intervention_name>
    <description>Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.</description>
    <arm_group_label>Paclitaxel + Pertuzumab + Margetuximab</arm_group_label>
    <other_name>Margenza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.</description>
    <arm_group_label>Paclitaxel + Pertuzumab + Trastuzumab</arm_group_label>
    <other_name>Herceptin</other_name>
    <other_name>Kanjinti</other_name>
    <other_name>Ogivri</other_name>
    <other_name>Herzuma</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th&#xD;
             edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor&#xD;
             size of 1.5 cm (in breast mass or axillary lymph node) determined by physical exam or&#xD;
             imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma&#xD;
             (T4d) are NOT eligible.&#xD;
&#xD;
          -  Centrally confirmed to have a low affinity CD16 germline genotype (FF or FV)&#xD;
&#xD;
          -  HER-2 positive by 2018 American Society of Clinical Oncology/College of American&#xD;
             Pathologists criteria, as assessed by standard institutional guidelines (central&#xD;
             testing is not required).&#xD;
&#xD;
          -  ER/PR determination is required. ER- and PR-assays should be performed by&#xD;
             immunohistochemical methods according to standard institutional guidelines&#xD;
&#xD;
          -  Bilateral breast cancers are allowed as long as both cancers are HER2-positive (as&#xD;
             defined in 3.1.2), or the contralateral cancer is a &lt;1 cm, ER+ tumor.&#xD;
&#xD;
          -  Patients with multifocal or multicentric disease are eligible if the treating&#xD;
             investigator hasdetermined the patient should be treated as HER2-positive.&#xD;
&#xD;
          -  Breast imaging should include dedicated ultrasound of the ipsilateral axilla. For&#xD;
             subjects with a clinically positive axilla based on exam or imaging, a fine needle&#xD;
             aspiration or core biopsy procedure will be performed to determine the presence of&#xD;
             metastatic disease in the lymph nodes (though lymph node sampling procedure need not&#xD;
             be resulted prior to patient's registration on trial, as long as all other eligibility&#xD;
             are met).&#xD;
&#xD;
          -  Men and women (with any menopausal status) ≥18 years of age are eligible.&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  Required laboratory values demonstrating adequate organ function:&#xD;
&#xD;
               -  ANC ≥ 1000/mm3&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dl&#xD;
&#xD;
               -  Platelets ≥ 100,000/mm3&#xD;
&#xD;
               -  Serum creatinine &lt; 1.5 x ULN (institutional) OR calculated GFR ≥ 60mL/min&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x ULN (institutional). For patients with Gilbert Syndrome,&#xD;
                  the direct bilirubin should be within the institutional normal range OR total&#xD;
                  bilirubin ≤ 2.0 mg/dL.&#xD;
&#xD;
               -  AST and ALT ≤ 2.5x ULN (institutional) Left ventricular ejection fraction (LVEF)&#xD;
                  ≥ 50%.&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test within 14&#xD;
             days of treatment start. Childbearing potential is defined as: those who have not been&#xD;
             surgically sterilized and/or have had a menstrual period in the past 12 months&#xD;
&#xD;
          -  Women of childbearing potential and men with partners of childbearing potential must&#xD;
             be willing to use one highly effective form of non-hormonal contraception or two&#xD;
             effective forms of non-hormonal contraception by the patient and/or partner and&#xD;
             continue its use for the duration of the study treatment and for 7 months after the&#xD;
             last dose of study treatment.&#xD;
&#xD;
          -  Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible.&#xD;
&#xD;
          -  Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any&#xD;
             contraindications to radiation therapy.&#xD;
&#xD;
          -  Non-English-speaking patients are eligible but will be exempt from patient-completed&#xD;
             questionnaires.&#xD;
&#xD;
          -  Willing and able to sign informed consent.&#xD;
&#xD;
          -  Willing to undergo breast biopsy for research purposes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women due to the teratogenic potential of the study drugs.&#xD;
&#xD;
          -  Active, unresolved infection requiring intervention&#xD;
&#xD;
          -  Receipt of intravenous antibiotics for infection within 7 days prior to registration.&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic &gt;180 mm Hg and/or diastolic &gt;100 mm Hg) or&#xD;
             clinically significant (i.e. active) cardiovascular disease: cerebrovascular&#xD;
             accident/stroke or myocardial infarction within 6 months prior to first study&#xD;
             medication, unstable angina, congestive heart failure (CHF) of New York Heart&#xD;
             Association (NYHA) Class II or higher, or serious cardiac arrhythmia requiring&#xD;
             medication.&#xD;
&#xD;
          -  Significant symptoms (Grade ≥ 2) from peripheral neuropathy.&#xD;
&#xD;
          -  Other concurrent serious diseases that may interfere with planned treatment, including&#xD;
             severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes.&#xD;
&#xD;
          -  Any prior treatment for the current breast cancer, including chemotherapy, hormonal&#xD;
             therapy, radiation, or experimental therapy.&#xD;
&#xD;
          -  Patients with any prior history of invasive breast cancer within the past 5 years are&#xD;
             not eligible. Non-metastatic invasive breast cancers diagnosed more than 5 years ago&#xD;
             and any other type of prior non-metastatic cancer is allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrienne Waks, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adrienne Waks, MD</last_name>
    <phone>617-632-6973</phone>
    <email>Adrienne_Waks@DFCI.HARVARD.EDU</email>
  </overall_contact>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nellie Novielli</last_name>
      <email>noviella@georgetown.edu</email>
    </contact>
    <investigator>
      <last_name>Claudine Isaacs, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacy Malloy</last_name>
      <email>stacy.k.malloy@medstar.net</email>
    </contact>
    <investigator>
      <last_name>Claudine Isaacs, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center at Silver Cross Hospital</name>
      <address>
        <city>New Lenox</city>
        <state>Illinois</state>
        <zip>60451</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center for Advanced Care Orland Park</name>
      <address>
        <city>Orland Park</city>
        <state>Illinois</state>
        <zip>60462</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrienne Waks, MD</last_name>
      <email>adrienne_waks@dfci.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Adrienne Waks, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Brigham Cancer Center - Foxborough</name>
      <address>
        <city>Foxboro</city>
        <state>Massachusetts</state>
        <zip>02035</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Sinclair</last_name>
      <phone>781-624-4800</phone>
      <email>nsinclair1@partners.org</email>
    </contact>
    <investigator>
      <last_name>Natalie Sinclair, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber at Milford</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <zip>01757</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Sinclair, MD</last_name>
      <email>NSINCLAIR1@PARTNERS.ORG</email>
    </contact>
    <investigator>
      <last_name>Natalie Sinclair, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber at South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas O'Connor, M.D.</last_name>
      <phone>781-337-9091</phone>
      <email>thomasp_o'connor@dfci.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Thomas O'Connor, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesus Anampa, MD</last_name>
      <email>janampa@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Jesus Anampa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center - Arnold Palmer at Mountain View</name>
      <address>
        <city>Greensburg</city>
        <state>Pennsylvania</state>
        <zip>15601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center - Arnold Palmer at Norwin</name>
      <address>
        <city>Irwin</city>
        <state>Pennsylvania</state>
        <zip>15642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Pavlick</last_name>
      <phone>713-798-7814</phone>
      <email>acpavlic@bcm.ed</email>
    </contact>
    <investigator>
      <last_name>Mothaffar Rimawi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Lewis</last_name>
      <email>plewis@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Paula Pohlmann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington Fred Hutchinson Cancer Care</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Yung, MD</last_name>
      <email>rlyung@seattlecca.org</email>
    </contact>
    <investigator>
      <last_name>Rachel Yung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>April 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Adrienne G. Waks</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Stage II Breast Cancer</keyword>
  <keyword>Stage III Breast Cancer</keyword>
  <keyword>HER2-positive Breast Cancer</keyword>
  <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>Paclitaxel</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Pertuzumab</mesh_term>
    <mesh_term>Margetuximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04425018
org study id: 20-068
nct id: NCT04425018
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine how well participants with stage II-III
      HER2-positive breast cancer respond to pre-operative treatment using one of two different
      combinations of drugs.

      Drugs and Combinations used:

        -  Paclitaxel, Pertzumab and Margetuximab (Margenza)

        -  Paclitaxel, Pertzumab and Trastuzumab (Herceptin)
This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab
      (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2
      positive breast cancer.

        -  The research study procedures include screening for eligibility and study treatment
           including laboratory evaluations, two mandatory research biopsies and follow up visits.

        -  Participants will be randomized, which means randomly assigned, to one of two treatment
           arms. The treatment arms in this study and the names of the study drugs in each arm are:

             -  Arm A: Paclitaxel, Pertzumab and Margetuximab

             -  Arm B: Paclitaxel, Pertzumab and Trastuzumab

      Participants will receive study treatment for 12 weeks prior to surgery and will be followed
      for 10 years after surgery. After surgery, some participants will continue to receive the
      study drug margetuximab for a year in total, if they respond very well to the first 12 weeks
      of treatment with margetuximab.

      It is expected that about 171 people will take part in this research study.

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug combination to learn whether the drug
      combination works in treating a specific disease. "Investigational" means that the drug
      combination is being studied.

      The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab
      (Herceptin), and pertuzumab as part of a pre-operative treatment option for stage II-III
      HER2-positive breast cancer.

      The U.S. Food and Drug Administration (FDA) has approved margetuximab (Margenza) for advanced
      HER2-positive breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of pathologic complete response (pCR)
time frame: 12 weeks
description: Compare rate of pathologic complete response (pCR, defined as RCB 0) in patients with the FF or FV CD16A genotype and anatomic stage II-III HER2+ breast cancer treated with 4 cycles of neoadjuvant TMP or THP
measure: Rate of pathologic complete response
time frame: 12 weeks
description: Compare rate of pCR (RCB 0) in patients treated with TMP or THP, according to hormone receptor-positive (HR+) or hormone receptor-negative (HR-) status
measure: Residual Cancer Burden (RCB) scores
time frame: 12 weeks
description: Assess Residual Cancer Burden (RCB) scores1 in patients treated with TMP or THP, overall and according to HR+ or HR- status. reported using the Residual Cancer Burden calculator from M.D Anderson:
measure: Radiographic response rate
time frame: 12 Weeks
description: Assess radiographic response to neoadjuvant therapy in patients treated with TMP or
THP, overall and according to HR+ or HR- status.Response criteria are based on the RECIST 1.1 criteria:
measure: Number of Participants with Treatment Related Adverse Events according to CTCAE v5.0
time frame: From first treatment to 12 weeks
description: Assessment of DLTs on Arm A during the first 21 days of treatment Maximum grade of all treatment-related adverse events according to CTCAE v5.0 Patient-reported outcomes
measure: Event-free survival rate (EFS)
time frame: From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Event-free survival rate (EFS) Patients with RCB 0 or 1
time frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Event-free survival rate (EFS)Patients with RCB 2 or 3
time frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Event-free survival rate (EFS) Patients randomized to neoadjuvant TMP
time frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Event-free survival rate (EFS) patients randomized to neoadjuvant THP
time frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Event-free survival rate (EFS) -Patients with pCR
time frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Event-free survival rate (EFS) -Patients without pCR
time frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI)
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI) RCB 0 or 1
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI) RCB 2 or 3
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI) Patients randomized to neoadjuvant TMP
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI) Patients randomized to neoadjuvant THP
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI) Patients with pCR
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence ror death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Recurrence-free interval rate (RFI) Patients without pCR
time frame: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
description: The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS)
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS) Patients with RCB 0 or 1
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS) Patients with RCB 2 or 3
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS) Patients randomized to neoadjuvant TMP
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS) randomized to neoadjuvant THP
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS) Patients with pCR
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
measure: Overall survival Rate (OS) Patients without CR
time frame: up to 10 years from definitive surgery.
description: The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
arm group label: Paclitaxel + Pertuzumab + Margetuximab
arm group type: Experimental
description: The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel- via IV, Day 1,8,15 of each cycle
Margetuximab via IV, Day 1 of each cycle
Pertuzumab via IV, Day 1 of each cycle
arm group label: Paclitaxel + Pertuzumab + Trastuzumab
arm group type: Experimental
description: The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel- via IV, Day 1,8,15 of each cycle
Pertuzumab via IV, Day 1 of each cycle
Trastuzumab via IV, Day 1 of each cycle
intervention type: Drug
intervention name: Paclitaxel
description: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
arm group label: Paclitaxel + Pertuzumab + Margetuximab
arm group label: Paclitaxel + Pertuzumab + Trastuzumab
other name: Taxol
other name: Onxal
intervention type: Drug
intervention name: Pertuzumab
description: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
arm group label: Paclitaxel + Pertuzumab + Margetuximab
arm group label: Paclitaxel + Pertuzumab + Trastuzumab
other name: Perjeta
intervention type: Drug
intervention name: Margetuximab
description: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
arm group label: Paclitaxel + Pertuzumab + Margetuximab
other name: Margenza
intervention type: Drug
intervention name: Trastuzumab
description: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
arm group label: Paclitaxel + Pertuzumab + Trastuzumab
other name: Herceptin
other name: Kanjinti
other name: Ogivri
other name: Herzuma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adrienne Waks, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
last name: Adrienne Waks, MD
phone: 617-632-6973
email: Adrienne_Waks@DFCI.HARVARD.EDU
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Adrienne G. Waks
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Paclitaxel
mesh term: Trastuzumab
mesh term: Pertuzumab
mesh term: Margetuximab
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu