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Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer

Primary Purpose

HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HER-2/neu peptide vaccine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission

  • Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:

    • Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques
    • Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI)
  • Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy
  • HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis
  • Patients must be human leukocyte antigen (HLA)-A2 positive
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1
  • Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine
  • Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study
  • Subjects of reproductive ability must agree to use contraceptives during the entire study period

Exclusion Criteria:

  • White blood cell (WBC) < 3000/mm^3
  • Hemoglobin (Hgb) < 10 mg/dl
  • Platelets < 100,000/mm^3
  • Serum creatinine > 2.0 mg/dl
  • Serum bilirubin > 1.5 x upper limit of normal
  • Any contraindication to receiving sargramostim (GM-CSF) based vaccine products
  • Concurrent enrollment in other treatment studies
  • New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina
  • Pregnant or breast-feeding women
  • History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV)
  • Active brain metastasis

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (HER-2/neu peptide vaccine)

Arm Description

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

Outcomes

Primary Outcome Measures

Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
Wilson score 90% confidence intervals will be reported.
Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.

Secondary Outcome Measures

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
All, severe or worse, serious and related events will be quantified.
The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0
All, severe or worse, serious and related events will be quantified.

Full Information

First Posted
November 15, 2012
Last Updated
April 9, 2017
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01729884
Brief Title
Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Study ended early due to slow enrollment
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (HER-2/neu peptide vaccine)
Arm Type
Experimental
Arm Description
Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
Intervention Type
Biological
Intervention Name(s)
HER-2/neu peptide vaccine
Other Intervention Name(s)
HER-2
Intervention Description
Given ID
Primary Outcome Measure Information:
Title
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
Description
Wilson score 90% confidence intervals will be reported.
Time Frame
Up to 4 weeks
Title
Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
Description
Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
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
Description
All, severe or worse, serious and related events will be quantified.
Time Frame
Up to 4 weeks
Title
The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0
Description
All, severe or worse, serious and related events will be quantified.
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below: Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI) Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis Patients must be human leukocyte antigen (HLA)-A2 positive Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1 Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study Subjects of reproductive ability must agree to use contraceptives during the entire study period Exclusion Criteria: White blood cell (WBC) < 3000/mm^3 Hemoglobin (Hgb) < 10 mg/dl Platelets < 100,000/mm^3 Serum creatinine > 2.0 mg/dl Serum bilirubin > 1.5 x upper limit of normal Any contraindication to receiving sargramostim (GM-CSF) based vaccine products Concurrent enrollment in other treatment studies New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina Pregnant or breast-feeding women History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV) Active brain metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lupe Salazar
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer

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