NeoPHOEBE: Pi3k inhibition in Her2 OverExpressing Breast cancEr A phase II, randomized, parallel cohort, two stage, double-blind, placebo-controlled study of neoadjuvant trastuzumab versus trastuzumab + BKM120 in combination with weekly paclitaxel in HER2

To evaluate the pathological complete response (pCR) rate irrespective of lymph node involvement, at the time of surgery in patients with HER2- overexpressing or amplified operable breast cancer randomized to neoadjuvant trastuzumab plus BKM120 (followed by trastuzumab plus BKM120 placebo plus paclitaxel) OR trastuzumab plus BKM120 (followed by trastuzumab plus BKM120 plus paclitaxel) separately for PIK3CA mutant and wild-type cohorts