<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/NCT02252887</url>
  </required_header>
  <id_info>
    <org_study_id>14-124</org_study_id>
    <nct_id>NCT02252887</nct_id>
  </id_info>
  <brief_title>Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy</brief_title>
  <official_title>Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hartford HealthCare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if a combination of drugs can help to treat breast&#xD;
      cancer. This is a Phase II study which will test whether this combination of drugs is&#xD;
      effective and will provide further information on side effects and safety. A standard&#xD;
      chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor.&#xD;
      The HER2 receptor is a growth protein on the surface of some breast cancer cells that&#xD;
      provides messages telling the breast cancer cell to grow. The standard chemotherapy will be&#xD;
      gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin)&#xD;
      and it is commonly given to women with advanced and early HER2 positive breast cancer. The&#xD;
      other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast&#xD;
      cancer. The drugs in this study are each individually approved for the treatment of&#xD;
      metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine&#xD;
      with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast&#xD;
      cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 12, 2015</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_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>progression free</measure>
    <time_frame>3 months</time_frame>
    <description>Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response</measure>
    <time_frame>2 years</time_frame>
    <description>Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety</measure>
    <time_frame>2 years</time_frame>
    <description>This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Metastatic HER2-Positive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Gemcitabine, Trastuzumab, and Pertuzuma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it &lt; 6 weeks prior to Cycle 1 Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <arm_group_label>Gemcitabine, Trastuzumab, and Pertuzuma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <arm_group_label>Gemcitabine, Trastuzumab, and Pertuzuma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pertuzumab</intervention_name>
    <arm_group_label>Gemcitabine, Trastuzumab, and Pertuzuma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ to 18&#xD;
&#xD;
          -  Stage IV HER2 (+) breast cancer&#xD;
&#xD;
          -  Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH&#xD;
             amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are&#xD;
             acceptable.&#xD;
&#xD;
          -  lECOG performance status 0 -1&#xD;
&#xD;
          -  Prior treatment with trastuzumab + pertuzumab (HP)-based therapy or pertuzumab-based&#xD;
             in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting.&#xD;
&#xD;
          -  ≤ 3 prior chemotherapies in the metastatic setting. Prior anthracycline, taxane,&#xD;
             gemcitabine, and anti-HER2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib,&#xD;
             TDM-1, etc.) are allowed. If patients received prior gemcitabine, it could not have&#xD;
             been combined with pertuzumab. Patients should have progression of disease on current&#xD;
             therapy.&#xD;
&#xD;
          -  Measurable or non-measurable disease.&#xD;
&#xD;
          -  LVEF ≥ 50%&#xD;
&#xD;
          -  Hematologic parameters: white blood cell (WBC) count of ≥ 3000/ul, absolute neutrophil&#xD;
             count (ANC) ≥ 1000/ul, platelets ≥ 100,000/ul, hemoglobin ≥10.0 g/dl&#xD;
&#xD;
          -  Non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, AST/ALT≤ 2.5 x upper limit of&#xD;
             normal (ULN), alkaline phosphatase ≤ 5 x ULN.&#xD;
&#xD;
          -  Creatinine ≤ 1.5 mg/dl&#xD;
&#xD;
          -  Patients with &quot;treated and stable&quot; brain lesions of a duration of ≥ 2 months may be&#xD;
             enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior unstable angina, myocardial infarction, CHF, uncontrolled ventricular&#xD;
             arrhythmias within 12 months&#xD;
&#xD;
          -  History of prior ≥ G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or&#xD;
             pertuzumab that warranted permanent cessation of this agent&#xD;
&#xD;
          -  History of hepatitis B or C&#xD;
&#xD;
          -  Pregnant patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chau Dang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hartford Healthcare Cancer Institute @ Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering at Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer 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>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gemcitabine,</keyword>
  <keyword>Trastuzumab</keyword>
  <keyword>Pertuzumab</keyword>
  <keyword>14-124</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>Gemcitabine</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Pertuzumab</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/NCT02252887
org study id: 14-124
nct id: NCT02252887
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
The purpose of this study is to see if a combination of drugs can help to treat breast
      cancer. This is a Phase II study which will test whether this combination of drugs is
      effective and will provide further information on side effects and safety. A standard
      chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor.
      The HER2 receptor is a growth protein on the surface of some breast cancer cells that
      provides messages telling the breast cancer cell to grow. The standard chemotherapy will be
      gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin)
      and it is commonly given to women with advanced and early HER2 positive breast cancer. The
      other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast
      cancer. The drugs in this study are each individually approved for the treatment of
      metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine
      with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast
      cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free
time frame: 3 months
description: Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).
measure: progression-free survival
time frame: 2 years
description: Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.
measure: response
time frame: 2 years
description: Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).
measure: overall survival
time frame: 2 years
description: Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.
measure: safety
time frame: 2 years
description: This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
arm group label: Gemcitabine, Trastuzumab, and Pertuzuma
arm group type: Experimental
description: The regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it < 6 weeks prior to Cycle 1 Day 1.
intervention type: Drug
intervention name: Gemcitabine
arm group label: Gemcitabine, Trastuzumab, and Pertuzuma
intervention type: Drug
intervention name: Trastuzumab
arm group label: Gemcitabine, Trastuzumab, and Pertuzuma
intervention type: Drug
intervention name: Pertuzumab
arm group label: Gemcitabine, Trastuzumab, and Pertuzuma
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chau Dang, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Gemcitabine
mesh term: Trastuzumab
mesh term: Pertuzumab