Clinical Trials

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.