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A phase 3 trial testing GLSI-100 in HR-positive / HER2-negative breast cancer, now recruiting.
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects is a phase 3 interventional study registered as NCT05232916, led by Greenwich LifeSciences, and recruiting on the registry. Official title: A Randomised, 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 Adjuvant Trastuzumab-based Therapy (FLAMINGO-01). Planned enrolment is 2250 participants (estimated). The study started in 2022-12-16 and primary completion is expected in 2031-12. No results have been posted on ClinicalTrials.gov.