Clinical Trial DRUG PH3-01
- "PRESENT": Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTM Treatment
- Principal Investigator
- Cesar Santa-Maria
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG PH3-01
- This study is being done to evaluate the safety and effectiveness of the investigational drug, NeuVax, in preventing the recurrence of node-positive, early stage breast cancer with low to intermediate HER2 expression.
- HER2/neu (also referred to as simply HER2) is a protein that is found on breast cancer cells in very large amounts about 20-30% of the time and in low to moderate amounts about 60-70% of the time. This protein is recognized by the immune system as being dangerous. Several different HER2 peptides used as vaccines have been studied in people with breast cancer and have been shown in laboratory studies to stimulate the immune system to recognize and kill cancer cells that have HER2 on their cell surfaces. The vaccines involve the mixing of the peptide with recombinant human granulocyte macrophage colony-stimulating factor (GM-CSF), an FDA-approved drug that stimulates the immune system in general and may help the vaccines work better. The vaccines have been found to be well tolerated in Phase 1 trials (the earliest human testing meant to show safety). Stimulation of the immune system by one of these peptide vaccines, called E75, appears to reduce the rate of breast cancer recurrence in people with Node Positive breast cancer (when cancer is found in the lymph nodes), who are at risk for recurrence after completion of all standard therapies (such as surgery, chemotherapy, and radiation therapy). NeuVax (E75 peptide plus GM-CSF) is not approved by the FDA. It is a protein vaccine being developed for use after completion of standard of care therapy for early stage breast cancer to potentially prevent recurrence of the cancer. The safety of NeuVax in humans has been tested in prior research studies. This study will continue to collect information on safety, and will test NeuVax’s effectiveness.
Some of the eligibility criteria include:
- Participants in this study must have a diagnosis of invasive breast cancer, which has been completely removed with surgery.
- Participants must have lymph nodes that were found to be positive for cancer invasion.
- Participants must be women who are 18 or older.
- Description of Treatment
- Participants in this study will be randomly assigned to one of two treatment groups. The study groups are: NeuVax (E75 peptide at a dose of 1000 micrograms plus GM-CSF at a dose of 250 micrograms), or a control (GM-CSF at a dose of 250 micrograms only, that does not contain the E75 peptide). The study drug is given by skin injections monthly for the first 6 months, and then every 6 months for a total of 11 doses, with the last injection at Month 36 (Year 3).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 18-Apr-15 08:12 AM
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