The trial also showed an early positive trend in event-free survival (EFS) favoring the T-DXd arm, as well as an improved safety profile with T-DXd vs dose-dense doxorubicin and cyclophosphamide followed by THP. The safety profiles of T-DXd and THP were consistent with the known safety profiles of each individual treatment, and no new safety signals were identified. Notably, an independent adjudication committee determined that rates of interstitial lung disease were similar between the T-DXd/THP and dose-dense doxorubicin/cyclophosphamide/THP arms. The FDA has set a Prescription Drug User Fee Act target action date of May 18, 2026, for their regulatory decision. Patients were randomly assigned 1:1:1 to receive 8 cycles of T-DXd monotherapy, 4 cycles of T-DXd followed by 4 cycles of THP, or 4 cycles of dose-dense doxorubicin and cyclophosphamide followed by 4 cycles of THP.1pCR rate served as the primary end point.