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abemaciclib plus aromatase inhibitor (n=328) vs. aromatase inhibitor (n=165)
randomized controlled trial
abemaciclib plus a nonsteroidal aromatase inhibitor
abemaciclib: PO 150mg twice daily during each 28-day cycle / anastrozole 1mg PO or letrozole 2.5mg PO during each 28-day cycle
placebo plus a nonsteroidal aromatase inhibitor
anastrozole 1mg PO or letrozole 2.5mg PO during each 28-day cycle
la/mBC - HR-positive - 1st line (L1)
double blind
158 sites in 22 countries
P3 / PFS at 1-sided at 0.025, with 1 IA (alpha=0.00025) and final with the rest of the alpha. / OS will be tested hierarchically (with 3 IA)
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