NCT03014076

Immunotherapy Vaccine and Herceptin in Breast Cancer

Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cancer Insight, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following: * Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab * Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab * Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab

Conditions

• Breastcancer

Interventions

Type	Name	Description
DRUG	GP2 peptide + GM-CSF vaccine plus trastuzumab	HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab
DRUG	Trastuzumab	HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.

Timeline

• Start date: 2008-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2017-01-09
• Last updated: 2017-01-09