Breastcancer Clinical Trial
Official title:
Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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