alpelisib plus letrozole (n=131) vs. letrozole (n=126)
randomized controlled trial
alpelisib plus letrozole
alpelisib: PO 300mg/per day / letrozole: PO 2.5mg/per day (all trt were self-administered)
letrozole
letrozole: PO 2.5mg/per day (all trt were self-administered)
la/mBC - HR positive - (neo)adjuvant (NA)
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib; patients randomized after this date were assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.
double blind
at 87 centers in 17 countries
P2 / Bayesian methods
Exploratory results
NEO-ORB (mutant cohort), 2019 NCT01923168
alpelisib plus letrozole (n=-9) vs. letrozole (n=126)
randomized controlled trial
alpelisib plus letrozole
alpelisib: PO 300mg/per day / letrozole: PO 2.5mg/per day (all trt were self-administered)
letrozole
letrozole: PO 2.5mg/per day (all trt were self-administered)
la/mBC - HR positive - (neo)adjuvant (NA)
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib; patients randomized after this date were assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.