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dalotuzumab plus ridaforolimus plus exemestane (n=40) vs. exemestane plus ridaforolimus (n=40)
randomized controlled trial
dalotuzumab plus ridaforolimus plus exemestane
dalotuzumab: IV 10 mg/kg/week / ridaforolimus: PO 10 mg for five consecutive days followed by two consecutive days off each week (qd 5 ×/week) repeated weekly / exemestane: PO 25 mg/day
ridaforolimus plus exemestane
ridaforolimus: PO 30 mg qd 5 ×/week / exemestane: PO 25 mg/day
la/mBC - HR-positive - 1st line (L1)
open label
from 31 sites in 15 countries (Europe, Israel, Peru, South Korea, Taiwan)
P2 / PFS at 1-sided at 10%
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