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.

Study Overview

• Status: Terminated
• Conditions: HER2-positive Breast Cancer; Male Breast Cancer; Stage IV Breast Cancer; Recurrent Breast Cancer
• Intervention / Treatment: Biological: HER-2/neu peptide vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment (HER-2/neu peptide vaccine); Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.	Biological: HER-2/neu peptide vaccine; Given ID; Other Names: HER-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC	Wilson score 90% confidence intervals will be reported.	Up to 4 weeks
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.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 weeks
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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (ESTIMATE): November 20, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 9, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Breast Neoplasms, Male
• Other Study ID Numbers: 7905 (OTHER: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); P50CA138293 (U.S. NIH Grant/Contract); NCI-2012-02223 (REGISTRY: CTRP (Clinical Trial Reporting Program))