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
Abstract
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.
Document Details
- Document Type
- Technical Report
- Publication Date
- May 01, 2008
- Accession Number
- ADA487069
Entities
People
- Mary L. Disis
Organizations
- University of Washington