Study design and patients
ypN0
SECONDARY
The KRISTINE study design and results from primary and secondary analyses have been reported elsewhere [The primary efficacy endpoint was locally determined pCR (ypT0/is, ypN0), assessed using samples taken at surgery following the completion of neoadjuvant therapy [The KRISTINE study protocol, which included a description of preplanned exploratory biomarker analyses, received ethics approval from the institutional review board or ethics committee at each study site, and all patients provided written informed consent. The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines and the Declaration of Helsinki.