NCT01729884

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	HER-2/neu peptide vaccine	Given ID

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-06-01
• First posted: 2012-11-20
• Last updated: 2017-04-11

Locations

1 site across 1 country: United States