Shown are Kaplan–Meier estimates of overall survival in the intention-to-treat population, stratified according to world region, number of prior chemotherapy regimens (0 or 1 vs. >1), and site of disease involvement (visceral vs. nonvisceral). The second interim analysis was conducted on the basis of 331 deaths and met the predefined O'Brien–Fleming stopping boundary. The data-cutoff date was July 31, 2012. Median follow-up was 18.6 months (range, 0 to 41) in the lapatinib–capecitabine group and 19.1 months (range, 0 to 40) in the T-DM1 group.