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alisertib plus paclitaxel (n=69) vs. paclitaxel (n=70)
randomized controlled trial
alisertib plus paclitaxel
alisertib: 40 mg twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle / weekly paclitaxel: 60 mg/m2 intravenously (IV) on days 1, 8, and 15 of a 28-day cycle
paclitaxel
weekly paclitaxel: 90 mg/m2 IV on days 1, 8, and 15 of a 28-day cycle
la/mBC - HR-positive - 2nd line (L2)
open label
22 sites in USA
P2 / PFS at 1-sided at 0.05 in each of the 2 cohorts (cohort 1 : ER-positive/HER2-negative and cohort 2 : TNBC)
EXPLORATORY RESULTS
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