Phase II Study of HER-2/Neu Intracellular Domain Peptide-Based Vaccine Administered to Stage IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab
Abstract
The cytotoxic T lymphocyte (CTL) has been considered the primary immune effector involved in mediating an anti-tumor response. Recent studies have demonstrated that "sensitization" of HER2 overexpressing tumor cells with trastuzumab, in vitro, will enhance the function of CTL specific for HER2. We have completed a Phase I study of a MER2 peptide based vaccine in women with HSR2 overepxressing breast cancers without toxicity, particularly autoimmune or cardiac toxicity. This proposal outlines a Phase II clinical trial designed to estimate survival in Stage IV HER2 positive breast cancer patients with no evidence of disease and receiving trastuzumab and a HER2 ICD peptide based vaccine. In addition to survival we will assess the safety of combined immunotherapy, the immunogenicity of the approach, and whether the development of HER2 specific immunity correlates with clinical response. If we find that vaccinating against breast cancer after optimal treatment prevents or slow disease recurrence resulting in improved survival, more universal vaccine approaches can be rapidly developed and tested for the juvant treatment of all breast cancers.
Document Details
- Document Type
- Technical Report
- Publication Date
- May 01, 2005
- Accession Number
- ADA437683
Entities
People
- Mary L. Disis
Organizations
- Seattle University