IPATunity130: A pivotal randomized phase III trial evaluating ipatasertib (IPAT) + paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered advanced triple-negative (TN) or hormone receptor-positive HER2-negative (HR+/HER2–) breast cancer (BC).

TPS1117Background: In the LOTUS trial in advanced TNBC, adding IPAT to first-line PAC improved progression-free survival (PFS; primary endpoint), particularly in patients (pts) with PIK3CA/AKT1/PTEN-altered tumors [Kim, Lancet Oncol 2017]. The pivotal double-blind placebo (PBO)-controlled randomized phase III IPATunity130 trial (NCT03337724) aims to confirm and build on findings from LOTUS. Methods: Eligible pts have ECOG performance status 0/1 and RECIST-measurable locally advanced/metastatic BC not amenable to resection with curative intent. Pts are allocated to either cohort A (TNBC; n≈249) or cohort B (HR+/HER2– not suitable for endocrine therapy; n≈201) according to their most recent locally assessed receptor status (in recurrent/metastatic tumor if available). In cohort A, any prior systemic therapy for advanced TNBC is prohibited, whereas cohort B pts may have received prior systemic therapy except chemotherapy for advanced BC. Tumor PIK3CA/AKT1/PTEN eligibility is tested centrally by next-generati...