A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

• Histologically confirmed TNBC, Stage I-III
• Residual invasive disease in the breasat and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy
• Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab
• No evidence of locoregional or distant relapse
• Surgical removal of all clinically evident disease
• ECOG PS 0-1
• No adjuvant systemic therapy
• LVEF > 50%
• No known germline BRCA mutation
• No Stage IV disease
• No history of prior invasive breast cancer
• No persistent toxicities from prior anticancer therapies
• No prior autoimmune or inflammatory disorders
• No known HIV

• Primary
  • Invasive DFS for Dato-DXd+durva compared to control therapy
• Seconday
  • Distant DFS for each comparison
  • OS for each comparison
  • Time to deterioration
  • Fatigue
  • Safety