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lapatinib plus trastuzumab (n=148) vs. lapatinib (n=148)
randomized controlled trial
lapatinib plus trastuzumab
lapatinib: PO 1000mg/day / trastuzumab: IV 2 mg/kg weekly (after the initial 4 mg/kg loading dose)
lapatinib monotherapy
lapatinib: PO 1500mg/day
cross-over population was comprised of 73 patients (49%) who, after documented disease progression after a minimum of 4 weeks of lapatinib monotherapy, opted to receive the combinationtreatment.
la/mBC - HER2 positive - 2nd Line (L2)
open label
88 centers in North America and Europe
P3 / PFS (in ITT population) at 2-sided alpha = 0.05 / no IA planned / The study was not powered for inference testing of the secondary end points.
the study met its primary endpoints, PFS was significantly increased in the combination group compare to lapatinib alone.
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