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
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)
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
Wilson score 90% confidence intervals will be reported.
Up to 4 weeks
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|