{"entity":{"id":"nct05232916","kind":"trial","name":"Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects","aka":["FLAMINGO-01"],"tldr":"A phase 3 trial testing GLSI-100 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"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.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05232916","url":"https://clinicaltrials.gov/study/NCT05232916"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["glsi-100"],"companies":["greenwich-lifesciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05232916","phase":"3","setting":"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 Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)","sponsor":"Greenwich LifeSciences","started":"2022-12-16","startedType":"actual","enrolled":2250,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05232916/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"glsi-100","kind":"drug","name":"GLSI-100","route":"/drugs/glsi-100/"}],"company":[{"id":"greenwich-lifesciences","kind":"company","name":"Greenwich LifeSciences","route":"/companies/greenwich-lifesciences/"}]}}