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)

breast cancer

IBCFS is defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality.

IDFS is defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or any cause mortality., The overall survival (OS) in the study population as defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until death from any cause., Quality of life as assessed by QLQ-C30 and FACT-GP5., The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment., Exploratory Endpoints: • Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests and immunologic assays. • Safety, efficacy, and immune response as defined above in non-HLA-A*02 breast cancer subjects

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