abemaciclib plus fulvestrant (n=446) vs. fulvestrant (n=223)
randomized controlled trial
abemaciclib plus fulvestrant
abemaciclib: 150mg twice per day, during each 28-days cycle (after amendment for reducing 200mg twice a day) / fulvestrant: IM 500mg on days 1 and 15 of the first cycle, and then the first day of each cycle
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of the first cycle, and then the first day of each cycle
la/mBC - HR-positive - 2nd line (L2)
double blind
P3 / hierarchical testing approach, with first PFS at 1-sided at 0.025, with 1 IA (with alpha at 0.00001) and final analysis at alpha at 0.02499996, and then OS, with 3 IA.