A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative
Contact:
NCT Number:
Protocol:
AAAU0138
Study Status:
Active/Enrolling
Population:
Adult
Phase:
III
The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a study medication called GP2 and the FDA-approved medication, granulocyte-macrophage colony-stimulating factor (GM-CSF) or sargramostim (Leukine®). It is thought that this medication will work by helping your immune system identify and remove cancer cells.
Are you Eligible? (Inclusion Criteria)
- Are you female and are you 18 and older?
- You are not currently receiving chemotherapy?
- Do you have stage 1-3 breast cancer?
Specialty Area(s)
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
