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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)
abemaciclib plus endocrine therapy (n=2808) vs. endocrine therapy (n=2829)
randomized controlled trial
abemaciclib plus endocrine therapy
abemaciclib: 150mg 2/day
endocrine therapy
la/mBC - HR-positive - 1st line (L1)
Exclusion criteria: Patients with occult breast cancer, metastatic disease, or node-negative breast cancer, and, after a protocol amendment, patients with inflammatory breast cancer, who received treatment with ET for breast cancer prevention, raloxifene, and/or a CDK4/6 inhibitor and with venous thromboembolic events
open label
603 sites in 38 countries (worldwide)
P3 / IDFS at 1-sided at 0.025 with 2 IA (1st IA at 0.0015, 2nd IA at 0.0092 and final analysis at 0.0220 all at 1-sided)
Adding abemaciclib to endocrine therapy increased significantly the IDFS in patients with HR-positive, and HER-negative
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.
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