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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2026

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At a glance

Most Recent Events

  • 03 Mar 2026 According to a Greenwich LifeSciences Inc media release, over the past 6 months, the Company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites.
  • 24 Feb 2026 According to a Greenwich LifeSciences Inc media release, data from the trial will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026
  • 24 Feb 2026 Results presented in the Greenwich LifeSciences Media Release

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