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)
← catalyst calendarNCT06103864 · readout in 343 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
625estimated
Sites
321
Countries
Argentina, Australia, Brazil +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-23 | actual | When the study began enrolling |
| Primary completion | 2027-07-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: Dato-DXd — also filed as Datopotamab deruxtecan (Dato-DXd, DS-1062a)
- Drug: Durvalumab — also filed as MEDI4736
- Drug: Paclitaxel
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
- Drug: Carboplatin
- Drug: Pembrolizumab
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS)
measured From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months).
Publications
- PMID 40297626 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · AZN's whole pipeline · Catalyst calendar · Every registered study · What changed