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)
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III
Principal Investigator: Krishnamurthy, Jairam
Contact Information:
Tanette Welsh
tanette.welsh@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05232916?term=NCT05232916&rank=1#participation-criteria
Summary
Primary Objective: 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.
Secondary Objectives: To assess secondary measures of 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 pCR at surgery) and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based standard of care therapy. To assess changes in quality of life as assessed by the EORTC Core Quality of Life questionnaire (QLQ-C30) and FACT-GP5.
To assess the safety and tolerability of GLSI-100 in the study population.
Exploratory Objective: To assess the immune response elicited by study therapy. To assess the efficacy of
GLSI-100 in non-HLA-A*02 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 pCR at surgery) and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based standard of care therapy.