PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxâ„¢ Treatment
Study Status
Open to Enrollment
Study Description
The purpose of this study is to evaluate the effectiveness of the experimental drug NeuVax in preventing the recurrence of node-positive, early stage breast cancer with low to intermediate HER2 expression. NeuVax is a protein vaccine being developed for use after completion of standard therapy for early stage breast cancer to potentially prevent recurrence of the cancer.
HER2 is a protein found in breast cancer cells and 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 are made by mixing the HER2 peptide with GM-CSF, an FDA-approved drug that stimulates the immune system and may help vaccines work better. 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, radiation therapy). NeuVax is made of the E75 peptide plus GM-CSF.
Study participants will be randomly assigned to receive either NeuVax or a control, which contains only GM-CSF. Participants will receive injections once a month for the first 6 months, and then every 6 months for a total of 11 doses. The last injection will be at Month 36 (Year 3). Follow-up will last for up to 10 years from the time of enrollment and consists of routine clinic visits every 3 to 6 months.
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Disease Status and/or Stage
HER2 1+/2+, Node Positive Breast Cancer
Sponsor
Galena Biopharma
Key Eligibility
- Women age 18 and older
- Node positive stage IIA, IIB or IIIA invasive breast cancer
- HER2 1+/2+
- Have completed standard of care adjuvant or neoadjuvant therapy
- Must have undergone total mastectomy or lumpectomy and radiation, plus axillary dissection
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Marta Cobham, RN
- (212) 821-0780
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]
