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 PositiveSubjects with Residual Disease or High-Risk PCR after both Neoadjuvant andPostoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)
Study of GLSI-100 in Female Patients with Breast Cancer
Sponsor: Greenwich Lifesciences, Inc.
Enrolling: Female Patients Only
IRB Number: AAAU0138
U.S. Govt. ID: NCT05232916
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: 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.
Julia McGuinness, MD
Do You Qualify?
Are you female and are you 18 and older? Yes No
Do you have stage 1-3 breast cancer? Yes No
Are you currently receiving chemotherapy? Yes No
You may be eligible for this study

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