Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer

HER2-positive Breast Cancer Clinical Trial

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

Status Terminated

Clinical Trial Summary

This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).

OUTLINE:

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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• HER2-positive Breast Cancer
• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

• NCT number: NCT01729884
• Study type: Interventional
• Source: University of Washington
• Status: Terminated
• Phase: Phase 2
• Start date: December 2012