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buparlisib plus letrozole (n=-9) vs. letrozole (n=-9)
randomized controlled trial
buparlisib plus letrozole
buparlisib: PO 100mg/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 / ORR at
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib (24); patients randomized after this datewere assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.
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