Statistical analysis
TNBC
SOMATIC MUTATION
The primary efficacy analysis population was the intention-to-treat population, including all eligible patients enrolled in the study. Safety was analyzed in all patients who received at least one dose of the study medication. The ORR and DCR with 95% CI were calculated using the Clopper–Pearson method. PFS and OS with 95% CI were assessed using the Kaplan–Meier method. In post hoc exploratory analyses, PFS for each cohort was analyzed by tissue somatic mutation. The association between the HER2 IHC scores and TNBC subtypes was examined using the chi-square test and Fisher’s exact test. Two-tailed Student’s SPSS (version 20) and R (version 4.1.1) were used for statistical analysis. The full statistical analysis plan is available in the protocol.