afatinib plus vinorelbine (n=339) vs. trastuzumab plus vinorelbine (n=169)
randomized controlled trial
afatinib plus vinorelbine
afatinib: PO 40 mg/day / vinorelbine: IV 25 mg/m² per week
trastuzumab plus vinorelbine
trastuzumab: IV 2 mg/kg per week after an initial loading dose of 4 mg/kg / vinorelbine: IV 25 mg/m² per week
la/mBC - HER2 positive - 2nd Line (L2)
Exclusion criteria: previous treatment with vinorelbine or an EGFR-targeted or HER2-targeted drug other than trastuzumab
open label
350 hospitals in 41 countries worlwilde
P3 / at 2-sided alpha of 0.05 in the ITT population. / evaluation of OS in the same manner as PFS, although the trial was not powered to evaluate OS and post-progression treatments were expected to confound results
Recruitement stopped on April 26, 2013 following recommandation of the independent data monitoring committee on the basis of a benefit–risk assessment, and conclude that there was a low likelihood of the study meeting the predefined criteria for increased progression-free survival with afatinib versus trastuzumab and that tolerability was lower in the afatinib group