<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/NCT03304080</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-0919</org_study_id>
    <nct_id>NCT03304080</nct_id>
  </id_info>
  <brief_title>Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast</brief_title>
  <official_title>A Multicenter, Phase I/II Trial of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Herbert Irving Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and&#xD;
      pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive,&#xD;
      HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim&#xD;
      to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and&#xD;
      anastrozole, which represents a novel and all biologic approach to the treatment of HR+,&#xD;
      HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential&#xD;
      biomarkers of response to palbociclib including cyclin D1, cyclin E1 and cyclin E2 expression&#xD;
      levels, CDK 2, 4, and 6 levels, phosphorylated retinoblastoma expression and p16 levels. The&#xD;
      researchers intend to use RNA sequencing to assess for other predictors of response in an&#xD;
      unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated&#xD;
      retinoblastoma expression as well as evaluate for potential mechanisms of resistance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>Phase 1/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>Dose-Limiting Toxicity (DLT)</measure>
    <time_frame>up to 3 months</time_frame>
    <description>The dose-limiting toxicity (DLT) for palbociclib when administered in combination with anastrozole, trastuzumab and pertuzumab. A DLT will be defined as:&#xD;
Grade 3 or 4 non-hematologic toxicity&#xD;
Grade 3 neutropenia lasting greater than 21 days&#xD;
Grade 3 or 4 neutropenia with neutropenic fever or&#xD;
Grade 4 hematologic toxicity events experienced within the first 4 weeks (1 cycle) of study treatment. These will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI's CTCAE) v4.0 toxicity criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD)</measure>
    <time_frame>up to 3 months</time_frame>
    <description>The maximum tolerated dose (MTD) for palbociclib when administered in combination with anastrozole, trastuzumab and pertuzumab. If &gt; 33 % of patients experience a dose limiting toxicity (DLT) at any dose level, the dose level below that level will be considered the MTD. Or if the highest level has been reached and ≤ 33% of patients have experienced dose limiting toxicity (DLT), that will be considered the MTD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Benefit Rate (CBR)</measure>
    <time_frame>average of 6 months</time_frame>
    <description>CBR will be measured by the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response, partial response, and stable disease for greater than or equal to 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>2 years</time_frame>
    <description>The time from the start of treatment until confirmed disease progression or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>incidence of adverse events as graded by the NCI CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Breast Neoplasms</condition>
  <condition>Breast Diseases</condition>
  <arm_group>
    <arm_group_label>HR-positive, Her2-positive Metastatic Breast Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women and men with HR-positive, HER2-positive Metastatic Breast Cancer on trial of anastrozole, palbociclib, trastuzumab and pertuzumab</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anastrozole</intervention_name>
    <description>1 mg orally daily, day 1 to day 28</description>
    <arm_group_label>HR-positive, Her2-positive Metastatic Breast Cancer</arm_group_label>
    <other_name>Arimidex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>Dose I: 100 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle (Phase 1 only) Dose II: 125 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle</description>
    <arm_group_label>HR-positive, Her2-positive Metastatic Breast Cancer</arm_group_label>
    <other_name>Ibrance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>8 mg/kg IV initial loading dose, followed by 6 mg/kg IV every 21 days</description>
    <arm_group_label>HR-positive, Her2-positive Metastatic Breast Cancer</arm_group_label>
    <other_name>Herceptin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pertuzumab</intervention_name>
    <description>840 mg IV followed by a maintenance dose of 420 mg IV every 21 days</description>
    <arm_group_label>HR-positive, Her2-positive Metastatic Breast Cancer</arm_group_label>
    <other_name>Perjeta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women or men with metastatic breast cancer, measurable or evaluable disease including&#xD;
             bone metastasis only (as per the Response Evaluation Criteria in Solid Tumors [RECIST]&#xD;
             v1.1)&#xD;
&#xD;
          -  No prior systemic treatment for metastatic breast cancer&#xD;
&#xD;
          -  Pathologic confirmation of metastatic breast cancer diagnosed by core needle biopsy&#xD;
&#xD;
          -  Metastatic breast cancer with any evidence of ER or PR positivity in ≥ 1% cells in&#xD;
             biopsy specimens from either a primary or metastatic site&#xD;
&#xD;
          -  Evidence of HER2 positive metastatic breast cancer in either a primary or metastatic&#xD;
             site, if 3+ by an IHC method defined as uniform membrane staining for HER2 in 10% or&#xD;
             more of tumor cells or demonstrate HER2 gene amplification by an ISH method (single&#xD;
             probe, average HER2 copy number ≥6.0 signals/cell; dual probe HER2/CEP17 ratio ≥2.0&#xD;
             with an average HER2 copy number ≥4.0 signals/cell; dual probe HER2/chromosome&#xD;
             enumeration probe (CEP) 17 ratio ≥2.0 with an average HER2 cop number &lt;4.0&#xD;
             signals/cell; and HER2/CEP17 ratio &lt;2.0 with an average HER2 copy number ≥6.0&#xD;
             signals/cell) or amplified by FISH &gt; 2.0. High average copy number of HER2 (≥6.0&#xD;
             signals/cell) is considered positive regardless of the HER2/CEP17 ratio.&#xD;
&#xD;
          -  Women or men 18 years and older&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2&#xD;
&#xD;
          -  Stable brain metastasis allowed (&gt;2 weeks, clinically stable post treatment with&#xD;
             surgery +/- radiation or radiation alone and off steroids)&#xD;
&#xD;
          -  Transthoracic echocardiogram with ejection fraction &gt; 50%&#xD;
&#xD;
          -  Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as&#xD;
             goserelin or leuprolide. Postmenopausal status is defined by any one of the following&#xD;
             criteria:&#xD;
&#xD;
               -  Prior bilateral oophorectomy.&#xD;
&#xD;
               -  Prior ovarian radiation for the purpose of ablation.&#xD;
&#xD;
               -  Age ≥ 60 years.&#xD;
&#xD;
               -  Age &lt; 60 and amenorrhea for 12 or more months (in the absence of chemotherapy,&#xD;
                  tamoxifen, or ovarian suppression) and FSH, LH, and estradiol in the&#xD;
                  postmenopausal range per local normal.&#xD;
&#xD;
          -  Written informed consent prior to beginning specific protocol procedures, including&#xD;
             expected cooperation of the patients for the treatment and follow-up, must be obtained&#xD;
             and documented according to the local regulatory requirements&#xD;
&#xD;
          -  A baseline CT chest/abdomen/pelvis and bone scan or PET/CT&#xD;
&#xD;
          -  Negative serum or urine pregnancy test within 7 days prior to starting treatment&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             prior to study entry, for the duration of study participation, and for 90 days&#xD;
             following completion of therapy. Should a woman become pregnant or suspect she is&#xD;
             pregnant while participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
        Note: Recommended methods of birth control are: The consistent use of an intrauterine&#xD;
        device (IUD), double barrier methods (diaphragm with spermicidal gel or condoms with&#xD;
        contraceptive foam), sexual abstinence (no sexual intercourse) or sterilization.&#xD;
&#xD;
        Men must agree to use a condom and not father a child for the duration of the study and for&#xD;
        90 days after completion of therapy&#xD;
&#xD;
        Laboratory values (≤ 28 days prior to registration)&#xD;
&#xD;
          -  Absolute Neutrophil Count (ANC) ≥ 1,500/mm3&#xD;
&#xD;
          -  Platelet Count ≥ 75,000/ mm3&#xD;
&#xD;
          -  Hg &gt;9 g/dL&#xD;
&#xD;
          -  Total Bilirubin ≤1.5 x upper limits of normal (ULN)&#xD;
&#xD;
          -  Serum ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastasis)&#xD;
&#xD;
          -  Creatinine ≤ 1.5 x ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HER2 negative metastatic breast carcinoma defined as 0 or 1+ by IHC or with a FISH&#xD;
             ratio (HER2 gene copy/ chromosome 17) &lt;2 if IHC 2+ by local institution standard&#xD;
             protocol&#xD;
&#xD;
          -  Any prior treatment for metastatic breast cancer. (excluding radiation therapy for the&#xD;
             purpose of ovarian ablation). Note: Prior adjuvant therapy with trastuzumab and&#xD;
             pertuzumab is permitted after a 6 month window following completion of adjuvant&#xD;
             therapy has passed.&#xD;
&#xD;
          -  Patients currently receiving anticancer therapies or who have received anticancer&#xD;
             therapies within 2 weeks of the start of study drug (including chemotherapy, radiation&#xD;
             therapy, and biologics). Patients who have received prior endocrine therapy for&#xD;
             fertility purposes will be eligible.&#xD;
&#xD;
          -  Patients, who have had a major surgery or significant traumatic injury within 4 weeks&#xD;
             of start of study drug, patients who have not recovered from the side effects of any&#xD;
             major surgery (defined as requiring general anesthesia) or patients that may require&#xD;
             major surgery during the course of the study&#xD;
&#xD;
          -  Prior treatment with any investigational drug within the preceding 2 weeks&#xD;
&#xD;
          -  Co-administration with strong CYP3A4 inducers (e.g., phenytoin, rifampin,&#xD;
             carbamazepine, St John's Wort, bosentan, efavirenz, etravirine, modafinil, and&#xD;
             nafcillin), strong CYP3A4 inhibitors (e.g., clarithromycin, indinavir, itraconazole,&#xD;
             ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir,&#xD;
             saquinavir, telaprevir, telithromycin, verapamil, and voriconazole), and CYP3A4&#xD;
             substrates (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus,&#xD;
             fentanyl, pimozide, quinidine, sirolimus and tacrolimus). For a current table of&#xD;
             Substrates, Inhibitors and Inducers please access the following&#xD;
             website:http://www.fda.gov/Drugs/DevelopmentApprovalProcess/&quot; See Appendix C.&#xD;
&#xD;
          -  Uncontrolled brain metastases&#xD;
&#xD;
          -  Leptomeningeal metastases&#xD;
&#xD;
          -  Other malignancies within the past 3 years except for adequately treated carcinoma of&#xD;
             the cervix or basal or squamous cell carcinomas of the skin.&#xD;
&#xD;
          -  Patients who have any severe and/or uncontrolled medical conditions or other&#xD;
             conditions that could affect their participation in the study such as:&#xD;
&#xD;
               -  Symptomatic congestive heart failure of New York heart Association Class III or&#xD;
                  IV&#xD;
&#xD;
               -  Unstable angina pectoris, symptomatic congestive heart failure, myocardial&#xD;
                  infarction within 6 months of start of study drug, serious uncontrolled cardiac&#xD;
                  arrhythmia or any other clinically significant cardiac disease&#xD;
&#xD;
               -  Severely impaired lung function as defined as spirometry and DLCO that is 50% of&#xD;
                  the normal predicted value and/or 02 saturation that is 89% or less at rest on&#xD;
                  room air&#xD;
&#xD;
               -  Uncontrolled diabetes as defined by fasting serum glucose &gt;1.5 x ULN&#xD;
&#xD;
               -  Active (acute or chronic) or uncontrolled severe infections&#xD;
&#xD;
               -  Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent&#xD;
                  hepatitis&#xD;
&#xD;
          -  Impairment of gastrointestinal function or gastrointestinal disease that may&#xD;
             significantly alter the absorption of palbociclib (e.g., ulcerative disease,&#xD;
             uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel&#xD;
             resection)&#xD;
&#xD;
          -  Patients with an active, bleeding diathesis&#xD;
&#xD;
          -  History of noncompliance to medical regimens&#xD;
&#xD;
          -  Patients unwilling to or unable to comply with the protocol&#xD;
&#xD;
          -  Ongoing alcohol or drug addiction&#xD;
&#xD;
          -  Female patients who are pregnant or breast feeding, or adults of reproductive&#xD;
             potential who are not using effective birth control methods. If barrier contraceptives&#xD;
             are being used, these must be continued throughout the trial by both sexes. Hormonal&#xD;
             contraceptives are not acceptable as a method of contraception. (Women of childbearing&#xD;
             potential must have a negative urine or serum pregnancy test within 7 days prior to&#xD;
             starting treatment)&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to palbociclib, anastrozole, trastuzumab or pertuzumab.&#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>Amy Tiersten, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel Comprehensive Cancer Center West</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perlmutter Cancer Center NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai West</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Columbia Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Amy Tiersten</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Neoplasms</keyword>
  <keyword>Breast Diseases</keyword>
  <keyword>Palbociclib</keyword>
  <keyword>Trastuzumab</keyword>
  <keyword>Pertuzumab</keyword>
  <keyword>Hormone Antagonists</keyword>
  <keyword>Anastrozole</keyword>
  <keyword>Arimidex</keyword>
  <keyword>Ibrance</keyword>
  <keyword>Perjeta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Pertuzumab</mesh_term>
    <mesh_term>Palbociclib</mesh_term>
    <mesh_term>Anastrozole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data collected during the course of this clinical trial will primarily be shared with other investigators and University staff, the IRB, FDA, and other reporting agencies, and/or transferred to other collaborators. Prior to transfer, the data collected must comply with, and must be limited by, the MSH's guidelines for Protecting the Rights and Privacy of Human Subjects.</ipd_description>
  </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/NCT03304080
org study id: GCO 17-0919
nct id: NCT03304080
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and
      pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive,
      HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim
      to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and
      anastrozole, which represents a novel and all biologic approach to the treatment of HR+,
      HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential
      biomarkers of response to palbociclib including cyclin D1, cyclin E1 and cyclin E2 expression
      levels, CDK 2, 4, and 6 levels, phosphorylated retinoblastoma expression and p16 levels. The
      researchers intend to use RNA sequencing to assess for other predictors of response in an
      unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated
      retinoblastoma expression as well as evaluate for potential mechanisms of resistance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-Limiting Toxicity (DLT)
time frame: up to 3 months
description: The dose-limiting toxicity (DLT) for palbociclib when administered in combination with anastrozole, trastuzumab and pertuzumab. A DLT will be defined as:
Grade 3 or 4 non-hematologic toxicity
Grade 3 neutropenia lasting greater than 21 days
Grade 3 or 4 neutropenia with neutropenic fever or
Grade 4 hematologic toxicity events experienced within the first 4 weeks (1 cycle) of study treatment. These will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI's CTCAE) v4.0 toxicity criteria.
measure: Maximum Tolerated Dose (MTD)
time frame: up to 3 months
description: The maximum tolerated dose (MTD) for palbociclib when administered in combination with anastrozole, trastuzumab and pertuzumab. If > 33 % of patients experience a dose limiting toxicity (DLT) at any dose level, the dose level below that level will be considered the MTD. Or if the highest level has been reached and ≤ 33% of patients have experienced dose limiting toxicity (DLT), that will be considered the MTD.
measure: Clinical Benefit Rate (CBR)
time frame: average of 6 months
description: CBR will be measured by the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response, partial response, and stable disease for greater than or equal to 6 months.
measure: Progression Free Survival
time frame: 2 years
description: The time from the start of treatment until confirmed disease progression or death from any cause, whichever occurs first.
measure: Incidence of adverse events
time frame: 2 years
description: incidence of adverse events as graded by the NCI CTCAE v4.0
arm group label: HR-positive, Her2-positive Metastatic Breast Cancer
arm group type: Experimental
description: Women and men with HR-positive, HER2-positive Metastatic Breast Cancer on trial of anastrozole, palbociclib, trastuzumab and pertuzumab
intervention type: Drug
intervention name: Anastrozole
description: 1 mg orally daily, day 1 to day 28
arm group label: HR-positive, Her2-positive Metastatic Breast Cancer
other name: Arimidex
intervention type: Drug
intervention name: Palbociclib
description: Dose I: 100 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle (Phase 1 only) Dose II: 125 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle
arm group label: HR-positive, Her2-positive Metastatic Breast Cancer
other name: Ibrance
intervention type: Drug
intervention name: Trastuzumab
description: 8 mg/kg IV initial loading dose, followed by 6 mg/kg IV every 21 days
arm group label: HR-positive, Her2-positive Metastatic Breast Cancer
other name: Herceptin
intervention type: Drug
intervention name: Pertuzumab
description: 840 mg IV followed by a maintenance dose of 420 mg IV every 21 days
arm group label: HR-positive, Her2-positive Metastatic Breast Cancer
other name: Perjeta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy Tiersten, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Amy Tiersten
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Breast Diseases
mesh term: Trastuzumab
mesh term: Pertuzumab
mesh term: Palbociclib
mesh term: Anastrozole
sharing ipd: Yes
ipd description: Data collected during the course of this clinical trial will primarily be shared with other investigators and University staff, the IRB, FDA, and other reporting agencies, and/or transferred to other collaborators. Prior to transfer, the data collected must comply with, and must be limited by, the MSH's guidelines for Protecting the Rights and Privacy of Human Subjects.