Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title: A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope HER-2/Neu Peptide Vaccine in Subjects Previously Treated for HER-2 Positive Breast Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the safety profile of a peptide-based vaccine targeting HER-2/neu, in patients with stage II/III HER-2 positive breast cancer.

II. To determine the ability of this vaccination protocol to elicit an immune response as measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies.

SECONDARY OBJECTIVES:

I. To compile descriptive follow-up data regarding vital status and disease recurrence.

II. To determine if HER-2/neu peptide 885 generates a T cell response that is specific to HER-2/neu or is cross-reactive with epidermal growth factor receptor (EGFR) protein.

III. To determine if the human leukocyte antigen (HLA)-DR epitopes contain HLA class I embedded epitopes.

OUTLINE:

Patients receive HER-2/neu peptide vaccine intradermally (ID) every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 2 additional years. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• HER2-positive Breast Cancer
• Male Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

• NCT number: NCT01632332
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2012
• Completion date: July 9, 2018