Statistical Analysis
The study was to be considered a success if the posterior probability that the true pCR rate exceeds 45% was ≥0.8. An interim analysis was to be conducted once 28 evaluable patients were assessed for pCR, and if ≥12 responses were observed, the study was to continue enrolling up to 60 patients.The pCR rate was defined as the percentage of patients achieving pCR after talazoparib treatment in both the evaluable and ITT populations by ICR and investigator, and related exact 2-sided 80% and 95% CIs were based on the Blaker’s method. RCB was calculated by ICR in both the evaluable and ITT populations, along with the corresponding exact 2-sided 95% CIs based on the Goodman’s method. Safety and tolerability of talazoparib were evaluated in the ITT population.Prespecified PRO analyses included the overall mean change from baseline (estimated using the longitudinal mixed-effects model) and the time to clinically meaningful deterioration (summarized using Kaplan-Meier methods). The time to clinically meaningful deterioration according to the GHS/QoL scale was defined as the first observation with a decrease of ≥10 points and no subsequent observations with a decrease of <10 points from baseline based on previously established thresholds.