Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01632332|
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 9, 2012|
|Actual Primary Completion Date :||March 24, 2014|
|Actual Study Completion Date :||July 9, 2018|
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-2
Other: laboratory biomarker analysis
- 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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|