Statistical analyses
TNBC
METASTATIC BREAST CANCER
This study was designed to provide adequate power to test the hypothesis for the primary endpoint of ORR by IRC in the efficacy evaluable TNBC cohort. A sample size of approximately 55 evaluable patients in the TNBC cohort was estimated to provide an alpha of 0.025 with 90% power using a binomial exact test to demonstrate a statistical difference between an estimated historical ORR of 25% with chemotherapy and an assumed ORR (by IRC) of 46% with pamiparib. The historical ORR of 25% was derived from ORRs for metastatic breast cancer with germline A subgroup analysis of ORR by IRC was conducted in baseline characteristic subgroups and presented as a forest plot. The association of g