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: 02 Mar 2026

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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 Jan 2026 Planned End Date changed from 30 Apr 2029 to 30 Sep 2030.
12 Jan 2026 Planned primary completion date changed from 31 Oct 2026 to 28 Jul 2027.
12 Aug 2025 Planned End Date changed from 26 Mar 2031 to 30 Apr 2029.

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