Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
|HER2-positive Breast Cancer Male Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer||Biological: HER-2/neu intracellular domain protein Procedure: leukapheresis Other: laboratory biomarker analysis Biological: sargramostim Other: immunologic technique Biological: synthetic tumor-associated peptide vaccine therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer|
- Relapse-free survival [ Time Frame: At 4 years ]
- Safety as assessed by NCI CTCAE version 3.0 [ Time Frame: Baseline and 1 month following last vaccination ]
- Immune response as assessed by HER2 specific T cell immunity and/or intramolecular epitope spreading [ Time Frame: Baseline, midpoint in the immunization schedule (prior to the 4th vaccine), 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations ]
- Correlation of RFS to the generation of an immune response [ Time Frame: Prior to the 4th vaccine, 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations ]
|Study Start Date:||March 2004|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
Biological: HER-2/neu intracellular domain protein
Other Names:Procedure: leukapheresis
Optional correlative studiesOther: laboratory biomarker analysis
Correlative studiesBiological: sargramostim
Other Names:Other: immunologic technique
Other Names:Biological: synthetic tumor-associated peptide vaccine therapy
1. To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine.
- To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab.
To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab.
- To determine the incidence of the development of T cell immunity specific for the HER2 ICD.
- To determine the incidence of the development of intramolecular epitope spreading.
- To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization.
- To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading).
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally (ID) once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and then annually thereafter for up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343109
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Mary Disis||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|