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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)

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Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2025

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Durvalumab (Primary) ; Capecitabine; Pembrolizumab
  • Indications Advanced breast cancer; Early breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROPION-Breast03
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 04 Feb 2025 Planned End Date changed from 27 Mar 2030 to 30 Jan 2030.
  • 04 Feb 2025 Status changed from recruiting to active, no longer recruiting.
  • 06 Jul 2023 Planned End Date changed from 26 Mar 2030 to 27 Mar 2030.

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