<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/NCT01729884</url>
  </required_header>
  <id_info>
    <org_study_id>7905</org_study_id>
    <secondary_id>NCI-2012-02223</secondary_id>
    <secondary_id>7905</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <secondary_id>P50CA138293</secondary_id>
    <nct_id>NCT01729884</nct_id>
  </id_info>
  <brief_title>Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer</brief_title>
  <official_title>Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well vaccine therapy works in treating patients with stage IV&#xD;
      hormone receptor positive breast cancer. Vaccines made from peptides may help the body build&#xD;
      an effective immune response to kill tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific&#xD;
      central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood&#xD;
      mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL)&#xD;
      peptide-based vaccine.&#xD;
&#xD;
      II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from&#xD;
      HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based&#xD;
      vaccine and characterize their function.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who&#xD;
      are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study ended early due to slow enrollment&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <primary_completion_date type="Actual">June 2013</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>Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Wilson score 90% confidence intervals will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>All, severe or worse, serious and related events will be quantified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>All, severe or worse, serious and related events will be quantified.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>HER2-positive Breast Cancer</condition>
  <condition>Male Breast Cancer</condition>
  <condition>Recurrent Breast Cancer</condition>
  <condition>Stage IV Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (HER-2/neu peptide vaccine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HER-2/neu peptide vaccine</intervention_name>
    <description>Given ID</description>
    <arm_group_label>Treatment (HER-2/neu peptide vaccine)</arm_group_label>
    <other_name>HER-2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with HER2+ stage IV breast cancer that have been maximally treated and not in&#xD;
             a complete remission&#xD;
&#xD;
          -  Patients must have measurable disease per imaging studies performed within 60 days of&#xD;
             enrollment as described below:&#xD;
&#xD;
               -  Extra skeletal disease that can be measured with conventional or spiral computed&#xD;
                  tomography (CT) techniques&#xD;
&#xD;
               -  Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG)&#xD;
                  positron emission tomography (PET) or magnetic resonance imaging (MRI)&#xD;
&#xD;
          -  Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or&#xD;
             bisphosphonate therapy&#xD;
&#xD;
          -  HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC)&#xD;
             of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH)&#xD;
             analysis&#xD;
&#xD;
          -  Patients must be human leukocyte antigen (HLA)-A2 positive&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =&lt; 1&#xD;
&#xD;
          -  Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic&#xD;
             steroids) 3 weeks prior to first vaccine&#xD;
&#xD;
          -  Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF)&#xD;
             measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) &gt;= the lower&#xD;
             limit of normal for the facility within 3 months of enrollment to study&#xD;
&#xD;
          -  Subjects of reproductive ability must agree to use contraceptives during the entire&#xD;
             study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  White blood cell (WBC) &lt; 3000/mm^3&#xD;
&#xD;
          -  Hemoglobin (Hgb) &lt; 10 mg/dl&#xD;
&#xD;
          -  Platelets &lt; 100,000/mm^3&#xD;
&#xD;
          -  Serum creatinine &gt; 2.0 mg/dl&#xD;
&#xD;
          -  Serum bilirubin &gt; 1.5 x upper limit of normal&#xD;
&#xD;
          -  Any contraindication to receiving sargramostim (GM-CSF) based vaccine products&#xD;
&#xD;
          -  Concurrent enrollment in other treatment studies&#xD;
&#xD;
          -  New York Heart Association functional class III-IV heart failure, symptomatic&#xD;
             pericardial effusion, or unstable angina&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  History of disorders associated with immunosuppression such as human immunodeficiency&#xD;
             virus (HIV)&#xD;
&#xD;
          -  Active brain metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lupe Salazar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <disposition_first_submitted>April 3, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>April 3, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 5, 2017</disposition_first_posted>
  <last_update_submitted>April 9, 2017</last_update_submitted>
  <last_update_submitted_qc>April 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Mary (Nora) Disis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms, Male</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01729884
org study id: 7905
secondary id: NCI-2012-02223
secondary id: 7905
secondary id: P30CA015704
secondary id: P50CA138293
nct id: NCT01729884
lead sponsor: 
collaborator: 
has dmc: No
This phase II trial studies how well vaccine therapy works in treating patients with stage IV
      hormone receptor positive breast cancer. Vaccines made from peptides may help the body build
      an effective immune response to kill tumor cells.
PRIMARY OBJECTIVES:

      I. To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific
      central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood
      mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL)
      peptide-based vaccine.

      II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from
      HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based
      vaccine and characterize their function.

      SECONDARY OBJECTIVES:

      I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who
      are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).

      OUTLINE:

      Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.

      After completion of study treatment, patients are followed up at 4 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
time frame: Up to 4 weeks
description: Wilson score 90% confidence intervals will be reported.
measure: Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
time frame: Up to 4 weeks
description: Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
measure: The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: Up to 4 weeks
description: All, severe or worse, serious and related events will be quantified.
measure: The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0
time frame: Up to 4 weeks
description: All, severe or worse, serious and related events will be quantified.
arm group label: Treatment (HER-2/neu peptide vaccine)
arm group type: Experimental
description: Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
intervention type: Biological
intervention name: HER-2/neu peptide vaccine
description: Given ID
arm group label: Treatment (HER-2/neu peptide vaccine)
other name: HER-2
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Lupe Salazar
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Mary (Nora) Disis
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Breast Neoplasms, Male