trastuzumab emtansine (n=495) vs. lapatinib plus capecitabine (n=496)
randomized controlled trial
trastuzumab emtansine
trastuzumab emtansine: IV 3,6mg/kg of body weight every 21 days
lapatinib plus capecitabine
lapatinib: PO 1250mg daily / capecitabine: PO 1000 mg per square meter of body surface area every 12hours on days 1 through 14 of each 21-day cycle / both molecules were self-administered a,d patients recorded their doses in a patient diary.
la/mBC - HER2 positive - 2nd Line (L2)
exclusion criteria: prior treatment with TDM-1, lapatinib or capecitabine, peripheral neuropathy of grade 3 or more, CNS metastases.
open label
213 centers in 26 countries
P3 / The hypothesis test for PFS was conducted at a 2-sided alpha of 0.05. If the PFS was statistically significant, OS was tested at a 2-sided alpha of 0.05. One IA for OS (p=0.0003) was planned at the beginning, and a 2nd IA (p=0.0037) was added to the SAP after the completion of the first IA, and the final OS analysis with p < 0.0494 (in the protocol). If both PE were statistically significant, secondary endpoints were tested in a prespecified order : PFS (investigator assessment), response rate (independent review), time to treatment failure, and time to symptom progression
trastuzumab emtasine increased significantly PFS and OS compare to lapatinib plus capecitabine