Endpoints and study hypotheses
ypN0, death
DISEASE, SECONDARY, RECURRENCE
The primary endpoint of the NACATRINE trial was pCR, which was defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery. The secondary endpoints were OS and DFS, defined as the time from treatment to death and the time from randomization to disease recurrence, respectively.The hypotheses of this exploratory analysis of the NACATRINE trial were that differentially expressed genes in pretreatment samples could be potential biomarkers for (1) pCR in the overall study population and (2) that there were differences in pCR between study arms.