A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Recruiting now · Phase 3
Conditions studied: Breast Cancer
In brief
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Key facts
- Study ID
- NCT06103864
- Run by
- AstraZeneca
- People needed
- 625
- Starts
- 2023-11-23
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Cincinnati, Ohio, United States (enrolling)
- Research Site — Nashville, Tennessee, United States (enrolling)
- Research Site — Saint Paul, Minnesota, United States (enrolling)
- Research Site — Stony Brook, New York, United States (enrolling)
- Research Site — Providence, Rhode Island, United States (enrolling)
- Research Site — Chattanooga, Tennessee, United States (enrolling)
- Research Site — Columbia, Maryland, United States (enrolling)
- Research Site — Detroit, Michigan, United States (enrolling)
- Research Site — Albuquerque, New Mexico, United States (enrolling)
- Research Site — New York, New York, United States (enrolling)
- Research Site — Cleveland, Ohio, United States (enrolling)
- Research Site — Miami, Florida, United States (enrolling)
- Research Site — Daphne, Alabama, United States (enrolling)
- Research Site — Plantation, Florida, United States (enrolling)
- Research Site — Aurora, Colorado, United States (enrolling)
- Research Site — Baton Rouge, Louisiana, United States (enrolling)
- Research Site — Chicago, Illinois, United States (enrolling)
- Research Site — Springdale, Arkansas, United States (enrolling)
- Research Site — New Haven, Connecticut, United States (enrolling)
- Research Site — St Louis, Missouri, United States (enrolling)
- Research Site — Glendale, California, United States (enrolling)
- Research Site — Des Moines, Iowa, United States (enrolling)
- Research Site — Sacramento, California, United States (enrolling)
- Research Site — Cincinnati, Ohio, United States (enrolling)
- Research Site — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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