A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) 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)
Objective
Primary Objectives: To demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.
Key Secondary: To demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of DDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy. To demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of OS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy. To demonstrate superiority of Dato-DXd monotherapy relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.
