Although the outcomes for the secondary endpoints of DFS-DCIS, DDFS, TTDR and CNS recurrence favoured neratinib, only DFS-DCIS achieved statistically significance. For the more clinically relevant endpoint of DDFS, statistical significance was not achieved. However, the study was not powered to demonstrate efficacy on this endpoint at the 0.05 level, and results are trending in the same direction as the primary endpoint.