This application is supported by da

This application is supported by data from a single pivotal study. Study 3144A2-3004-WW was a multicentre, randomized, double-blind, placebo-controlled trial of neratinib in women with early stage HER2+ breast cancer. The primary objective of this study was to compare iDFS of women with earlystage HER2+ breast cancer who received neratinib or placebo, following trastuzumab in the adjuvant setting. The eligibility criteria defined a HER2+ early breast cancer population who had received locoregional surgery ± radiotherapy, as well as standard of care chemotherapy and trastuzumab. Following a protocol amendment, patients who were node negative or had received the last dose of trastuzumab ≥ 1 year previously were excluded. A total of 2840 patients were randomized, 1420 to each treatment arm of which 1408 were dosed in each arm.