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

This study is currently recruiting participants.
Verified January 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01729884
First received: November 15, 2012
Last updated: January 30, 2014
Last verified: January 2014

November 15, 2012
January 30, 2014
December 2012
November 2015   (final data collection date for primary outcome measure)
  • Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
Same as current
Complete list of historical versions of study NCT01729884 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    All, severe or worse, serious and related events will be quantified.
Toxicity 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 ] [ Designated as safety issue: Yes ]
The number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be quantified.
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Biological: HER-2/neu peptide vaccine
    Given ID
    Other Name: HER-2
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
Interventions:
  • Biological: HER-2/neu peptide vaccine
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
November 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Not Provided
United States
 
NCT01729884
7905, NCI-2012-02223, 7905, P30CA015704, P50CA138293
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Lupe Salazar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP