lapatinib plus capecitabine (n=43) vs. trastuzumab plus capecitabine (n=43)
randomized controlled trial
lapatinib plus capecitabine
lapatinib: 1250 mg/day / capecitabine: 2000 mg/m2/day on days 1-14 every 3 weeks
trastuzumab plus capecitabine
trastuzumab: 4 mg/kg loading then 2 mg/kg weekly or 8 mg/kg loading then 6 mg/kg every 3 weeks / and capecitabine: 2500 mg/m2/day on days 1-14 every 3 weeks
la/mBC - HER2 positive - 2nd Line (L2)
Exclusion criteria: patients with symptomatic brain metastases
open label
28 institutions in Japan
P2 / PFS at 1-sided at 0.10
the study did not met its primary endpoint, lapatinib plus capecitanine did not improve PFS compare to trastuzumab plus capecitabine
EGF104900, 2010 NCT00320385
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.