Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
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.
HER2-positive Breast Cancer
Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Biological: HER-2/neu peptide vaccine
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope HER-2/Neu Peptide Vaccine in Subjects Previously Treated for HER-2 Positive Breast Cancer|
- 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. [ Time Frame: Assessed up to 2 years following final immunization ] [ Designated as safety issue: Yes ]The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- 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 [ Time Frame: 30 months ] [ Designated as safety issue: No ]Immune responses to to the vaccine components will be periodically assessed using various assays measuring cytokine release, frequency of T cells, and antibody generation.
- Disease-free survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity.
Biological: HER-2/neu peptide vaccine
Other Name: HER-2Other: laboratory biomarker analysis
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632332
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Keith Knutson, Ph.D.||Mayo Clinic|
|Principal Investigator:||Amy Degnim, M.D.||Mayo Clinic|
|Study Chair:||Kimberly Kalli, Ph.D.||Mayo Clinic|
|Study Chair:||Timothy Hobday, M.D.||Mayo Clinic|