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.