Endpoints
tumor, PD, primary tumor, ypN0, Cancer
TUMOR, INVASIVE CANCER, SECONDARY, PRIMARY TUMOR, CANCER
The primary endpoint was pCR in the evaluable population assessed by ICR, and defined as the absence of invasive cancer in the breast and axillary lymph nodes on H&E staining of the complete resected breast specimen, and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer staging system).Isolated tumor cells (ITCs) were not specifically collected, therefore, no data on ITCs are available. Key secondary endpoints included pCR rate in the intent-to-treat (ITT) population assessed by ICR, and pCR by investigator assessment in both ITT and evaluable populations as well as RCB by ICR in both populations. All patients who took ≥1 dose of talazoparib were included in the ITT population and evaluated for efficacy and safety.RCB is a 4-category index derived from primary tumor dimensions, cellularity of the tumor bed, and axillary nodal burden. RCB 0 refers to no residual invasive cancer, or pCR. RCB I refers to minimal RCB, RCB II to moderate RCB, and RCB III to extensive RCB (PD).