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ribociclib plus fulvestrant (n=484) vs. fulvestrant (n=242)
randomized controlled trial
ribociclib plus fulvestrant
ribociclib: PO 600mg per day, 3-weeks on and 1-week off / fulvestrant: IM 500mg on day 1 of each 28-day cycle with an additional dose on day 15 of cycle 1
placebo plus fulvestrant
fulvestrant: IM 500mg on day 1 of each 28-day cycle with an additional dose on day 15 of cycle 1
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria: previsous treatment with fulvestrant or CDK4/6 inhibitors
double blind
174 study sites in 30 countries
P3 / PFS at 1-sided at 0.025 (with no IA) / hierarchical testing strategy for OS at 1-sided at 0.025 (1st IA: 0.00013, 2nd IA: 0.01129, final analysis)
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