Accession Number : ADA533841


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


Descriptive Note : Annual rept. 27 Apr 2009-26 Apr 2010, Phase 2


Corporate Author : SEATTLE UNIV WA


Personal Author(s) : Disis, Mary L


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a533841.pdf


Report Date : May 2010


Pagination or Media Count : 11


Abstract : The primary purpose of this grant is to determine the relapse free survival benefit with locally advanced and stage IV HER2 positive breast cancer patients vaccinated with a HER2 ICD peptide-based vaccine while receiving maintenance trastuzumab. The scope of work includes a Phase II single arm study of a HER2 ICD peptide-based vaccine given concurrently with trastuzumab. Thirty-two patients have been enrolled during the last reporting period. All adverse events reported for these fourteen subjects are of low grade. The study has been monitored by the Fred Hutchinson Cancer Research Center without remarkable findings. Patients have developed significant T cell immune responses to the vaccine as well as epitope spreading indicating a Type I immune response is being elicited. Planned interim analysis half way through the trial suggests clinical benefit of the approach.


Descriptors :   *BREAST CANCER , CLINICAL MEDICINE , ADVERSE CONDITIONS , RESPONSE(BIOLOGY) , SURVIVAL(PERSONNEL) , IMMUNITY , CELLS(BIOLOGY) , VACCINES , PEPTIDES , T LYMPHOCYTES


Subject Categories : Anatomy and Physiology
      Medicine and Medical Research


Distribution Statement : APPROVED FOR PUBLIC RELEASE