a near-significant trendP = .053
63 Although no significant differences were noted in the pCR rate between the buparlisib and placebo arms (32% v 40%), a near-significant trend was observed in the overall response rate (68.6% v 33%; P = .053) and a significant decrease was noted in Ki67 levels (75% v 26.7%; P = .021) favoring buparlisib in the subgroup of patients with HR+/HER2+ tumors. 63 Only eight of 50 enrolled subjects had PIK3CA mutations. 63 The study planned to recruit 256 patients but suspended recruitment early because of hepatotoxicity.