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A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

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Trial Profile

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2024

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Durvalumab (Primary) ; Carboplatin; Gemcitabine; Paclitaxel; Pembrolizumab
  • Indications Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROPION-Breast05
  • Sponsors AstraZeneca

    • Most Recent Events

    • 23 Jan 2024 Planned End Date changed from 13 Apr 2029 to 23 Apr 2029.
    • 23 Jan 2024 Planned primary completion date changed from 14 Sep 2026 to 1 Sep 2026.
    • 18 Dec 2023 According to a Daiichi Sankyo Company media release, first patient has been dosed in this study.

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