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

Phase 2

Terminated

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

• Registration Number: NCT01729884
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-20
• Study Start: 2012-12
• Primary Completion: 2013-06
• Status Verified: 2017-04
• Disposition First Submitted: 2017-04-03
• Disposition First Submitted QC: 2017-04-03
• Disposition First Posted: 2017-04-05
• Last Update Submitted: 2017-04-09
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (HER-2/neu peptide vaccine)	HER-2/neu peptide vaccine	Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.

Primary Outcome Measures

Name	Time	Method
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC	Up to 4 weeks	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	Up to 4 weeks	Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.

Secondary Outcome Measures

Name	Time	Method
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	Up to 4 weeks	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	Up to 4 weeks	All, severe or worse, serious and related events will be quantified.

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States