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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%
ganitumab plus endocrine therapy (n=-9) vs. endocrine therapy (n=-9)
randomized controlled trial
ganitumumab plus exemestane or fulvetrant
ganitumab: IV 12mg/kg once every 2 weeks on day 1 and 15 of every cycle (28-day cycle) / endocrine therpay: fulvestrant: IM 500mg on day 1 and 250mg on day 15, 29 and every 28 days thereafter or exemestane: PO 25mg daily
placebo plus exemestane or fulvestrant
endocrine therpay: fulvestrant: IM 500mg on day 1 and 250mg on day 15, 29 and every 28 days thereafter or exemestane: PO 25mg daily
Patients assigned to placebo could switch toopen-label ganitumab if disease progressed
la/mBC - HR-positive - 2nd line (L2)
double blind
at 58 centres in the USA, Europe, Canada, and Australia
P2 / The primary objective was to estimate the effects of ganitumab; p values are descriptive as no formal hypothesis was tested.
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