buparlisib plus fulvestrant (n=188) vs. fulvestrant (n=184)
randomized controlled trial
buparlisib plus fulvestrant
buparlisib: PO 100mg/day starting on day 15 of cycle 1 to receive / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
la/mBC - HR positive - L2 - PIK3CA mutant
double blind
from 267 centres in 29 countries (Asia, Australia, Europe, North and South America, South Africa)
P3 / alpha at 1-sided at 0.025 -> split between PFS (main): p=0.02, then only if PFS (main) is significant, test of the PFS (full pop) p=0.014. For PFS (PI3K activated) p=0.005 but if PFS (main) is significant: p=0.01). / For OS (main): p=0.001 if PFS main is significant and OS (full pop) is not significant or p=0.015 if PFS (main), PFS (full pop) and OS (full pop) are all significant. For OS with PI3K activated, p=0.01 if PFS (main) and PFS (PI3K activated) are significant or p=0.005 if only PFS (PI3K activated) is significant. For OS (full pop), p=0.014 if only PFS (main) is sifnificant, or p=0.015 if PFS (main), PFS (full pop) and OS (main) are significant
buparlisib did not improve PFS in patients with a PI3K pathway activated. Therefore, OS was not tested