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Rochester, Minn.
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Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
Location:
Rochester, Minn.
Trial status:
Open for Enrollment
Why is this study being done?
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.
NCT ID:
NCT01632332
IRB Number:
11-005844
Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Office 507-538-7623