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Flamingo-01
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).
- Ouvert à Paris depuis le : 13/12/2024
- Ouvert à Saint-Cloud depuis le : 21/05/2024
- Public cible : Adult
- Phase : Phase III
Description de l'essai
To assess the efficacy of GLSI-100 compared to placebo in HLA-A*02 positive and HER2/neu positive breast cancer subjects who have a high risk of disease recurrence (stage I, II, or III at presentation with residual disease at surgery or stage III at presentation with pathologic complete response [pCR] at surgery) and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based standard of care therapy.
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