The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.
PRIMARY OBJECTIVES: I. To determine the safety profile of a peptide-based vaccine targeting HER-2/neu, in patients with stage II/III HER-2 positive breast cancer. II. To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies. SECONDARY OBJECTIVES: I. To compile descriptive follow-up data regarding vital status and disease recurrence. II. To determine if HER-2/neu peptide 885 generates a T cell response that is specific to HER-2/neu or is cross-reactive with epidermal growth factor receptor (EGFR) protein. III. To determine if the human leukocyte antigen (HLA)-DR epitopes contain HLA class I embedded epitopes. OUTLINE: Patients receive HER-2/neu peptide vaccine intradermally (ID) every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 2 additional years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Given ID
Correlative studies
Mayo Clinic
Rochester, Minnesota, United States
Proportion of patients who experience toxicities of attribution during the course of treatment (grades 3-5 of the NCI's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0) for 2 years.
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Time frame: Assessed up to 2 years following final immunization
To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies
Immune responses to to the vaccine components will be periodically assessed using various assays measuring cytokine release, frequency of T cells, and antibody generation.
Time frame: 30 months
Disease-free survival
Disease-free survival is defined as the time from registration to documentation of disease recurrence, second primary, or death without disease recurrence or second primary. The distribution of disease-free and overall survival times will be estimated using the method of Kaplan-Meier.
Time frame: 30 months
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