Phase II Study of HER-2/neu Intracellular Domain Peptide-Based Vaccine Administered to Stage IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab
Annual rept. 27 Apr 2005-26 Apr 2006
SEATTLE UNIV WA
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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. Patients enrolled will be HER2 over expressing 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. The vaccine has been manufactured, vialed, and tested for quality assurance. The study has been approved by both the FDA and our Human Subjects Division, and we are currently waiting for the approval of the USAMRMC HSRRB to approve this project so we may begin enrolling subjects into this study.
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