SOLAR-1 (patients with PIK3CA mutant status), 2019 NCT02437318
alpelisib plus fulvestrant (n=169) vs. fulvestrant (n=172)
randomized controlled trial
alpelisib plus fulvestrant
alpelisib: PO 300 mg to be taken with food every day / 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 - 2nd line (L2)
double blind
in 198 trial centers in 34 countries
P3 /overall type I error at 1-sided at 2.5% level, with PFS in patients with PIK3CA mutant (1-sided at 2.0%) and PFS in patients with PIK3CA non-mutant (1-sided at 0.5%). / 1IA for efficacy for the first PFS, p = 0.0001 (and 0.0199 for the final analysis) / The type I error probability was controlled using an O’Briene-Fleming spending function independent of the Haybittlee-Peto spending function used for PFS; final OS would be statistically significant if P=< 0.0161.
SOLAR-1 (patients without PIK3CA mutant status), 2019 NCT02437318
alpelisib plus fulvestrant (n=115) vs. fulvestrant (n=116)
randomized controlled trial
alpelisib plus fulvestrant
alpelisib: PO 300 mg to be taken with food every day / 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 - 2nd line (L2)
double blind
in 198 trial centers in 34 countries
P3 / overall type I error at 1-sided at 2.5% level, with PFS in patients with PIK3CA mutant (1-sided at 2.0%) and PFS in patients with PIK3CA non-mutant (1-sided at 0.5%). / 1IA for efficacy for the first PFS, p = 0.0001 (and 0.0199 for the final analysis) / hierarchical testing approach for OS, at 2-sided at 2%