Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2

NACompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Breast Cancer
Interventions
BIOLOGICAL

HER-2/neu intracellular domain protein

300mcg (100mcg/peptide) of the HER2 ICD peptide mixture per skin test. This will be injected intradermally on the back at 6 months post active immunization.

OTHER

flow cytometry

This is a laboratory test used to assess the antigen specific T cell population.

OTHER

immunohistochemistry staining method

This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.

PROCEDURE

biopsy

A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.

OTHER

Sterile water placement

100mcg of sterile water will be administered intradermally on the back and serves as a negative control for the laboratory analysis. This will be injected intradermally on the back at 6 months post active immunization.

Trial Locations (2)

98109

Tumor Vaccine Group at the University of Washington, Seattle

98109-1024

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Washington

OTHER

NCT00363012 - Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2 | Biotech Hunter | Biotech Hunter