Phase II Study of HER-2/neu Intracellular Domain Peptide-Based Vaccine Administered to Stage IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab

摘要

The primary purpose of this grant is to determine the overall survival benefit in Stage IV HER2 positive breast cancer patients vaccinated with a HER2 ICD peptide-based vaccine while receiving maintenance trastuzumab. The scope of the work includes a Phase II single arm study of a HER2 ICD peptide based vaccine given concurrently with trastuzumab. Six patientshave been enrolled during the last reporting period. All adverse events reported for these six subjects are of low grade. Patients enrolled will be HER2 overexpressing stage IV breast cancer patients who have been treated to a clinical complete remission or have stable bone only disease and are within 6 months of starting maintenance trastuzumab. There have been no major findings to date.