Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
|HER2-positive Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Biological: HER-2/neu peptide vaccine||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer|
- Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC [ Time Frame: Up to 4 weeks ]Wilson score 90% confidence intervals will be reported.
- Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets [ Time Frame: Up to 4 weeks ]Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
- The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 4 weeks ]All, severe or worse, serious and related events will be quantified.
- The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0 [ Time Frame: Up to 4 weeks ]All, severe or worse, serious and related events will be quantified.
|Study Start Date:||December 2012|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
Biological: HER-2/neu peptide vaccine
Other Name: HER-2
I. To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL) peptide-based vaccine.
II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based vaccine and characterize their function.
I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).
Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.
After completion of study treatment, patients are followed up at 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729884
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Lupe Salazar||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|