Eligibility Criteria
toxicities, TNBC
BRAIN METASTASIS, DISEASE, METASTASIS, METASTATIC DISEASE
Main eligibility criteria were: ≥18 years; histologically confirmed TNBC defined by ER or PR ≤ 10% by IHC and HER2 negative per ASCO/CAP guidelines; ECOG performance status 0-1; life expectancy ≥3 months; RECIST 1.1 measurable disease for Arm C only (patients on Arms A and B could have non–measurable disease), available baseline archival tissue for PIK3CA/AKT/mTOR status, and adequate organ function. Main exclusion criteria included unresolved grade 3 toxicities, prior exposure to PIK3CA/AKT/mTOR pathway inhibitors, prior exposure to carboplatin (Arms A and B) for metastatic disease, prior exposure to paclitaxel (Arm A) for metastatic disease, prior exposure to capecitabine or ICIs (Arm C) in the metastatic setting, or untreated or unstable brain metastasis or leptomeningeal metastasis.