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: 29 Aug 2025

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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

12 Aug 2025 Planned End Date changed from 26 Mar 2031 to 30 Apr 2029.
12 Aug 2025 Planned primary completion date changed from 1 Dec 2026 to 31 Oct 2026.
29 Apr 2025 Planned End Date changed from 23 Apr 2029 to 26 Mar 2031.

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