Phase II Study of a HER-2/neu (HER2) Intracellular Domain (ICD) Peptide- Based Vaccine Administered to Stage IIIB and IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab Monotherapy; Annual rept. 27 Apr 2007-26 Apr 2008

摘要

The primary purpose of this grant is to determine the overall survival (OS) benefit in Stage IIIB and IV HER2 positive breast cancer patients vaccinated with a HER2 intracellular domain (ICD) peptide-based vaccine while receiving maintenance trastuzumab. Patients enrolled will be HER2 overexpressing stage IIIB and IV breast cancer patients who have been treated to a clinical complete response remission or have stable bone only disease and are within 6 months of starting maintenance trastuzumab. The scope of the work includes a Phase II, nonrandomized, single arm study of a HER2 ICD peptide- based vaccine given concurrently with trastuzumab. Ten subjects have been enrolled during the last reporting period. All adverse events reported for these ten subjects are grades 1 and 2. There have been no major findings to date.