NCT01632332

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	HER-2/neu peptide vaccine	Given ID
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-07-09
• Primary completion: 2014-03-24
• Completion: 2018-07-09
• First posted: 2012-07-02
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States