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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
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