At a glance
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Phase Ib Trial of HER2/Neu Peptide (E75) Vaccine in Node Negative Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating E75 + GM-CSF vaccine for Breast Cancer. Completed, enrolled 95 participants across 2 sites.
Detailed Summary
The objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in vivo cellular immune response to the peptide vaccine yet limit toxicity. 3. To determine the optimal inoculation schedule to elicit an in vivo cellular immune response to the peptide vaccine. 4. To correlate the efficiency of eliciting an in vivo cellular immune response to the peptide vaccine with the degree of HER2/neu expression in the patient's tumor.
Study Details
Timeline
Interventions
The 1 ml by volume vaccine is administered intradermally in 0.5 ml inoculums at two different sites within 5 cm of each other on an extremity. Vaccinations will be given according to the schedule the patient has been assigned and will be administered in the same lymph node draining area (same arm or thigh). In addition, an optional booster inoculation as requested by previously vaccinated patients will be offered every 6 months for the duration of the protocol. The dose will be determined by the PI based on the patient's response to the initial vaccination series.