A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
← catalyst calendarNCT05629585 · readout in 396 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo, SWOG Clinical Trials Partnerships, LLC.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,174actual
Sites
276
Countries
Belgium, Brazil, Canada +14
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 | 2022-11-28 | actual | When the study began enrolling |
| Primary completion | 2027-09-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-01-30 | estimated | The whole study's end, after follow-up |
| First posted | 2022-11-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-15 | 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: Capecitabine — also filed as XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord
- Drug: Pembrolizumab — also filed as KEYTRUDA®
Primary outcome
what the primary-completion date above is the date OFInvasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT
measured From randomisation to date of the event, up to 57 months from first subject in
Publications
- PMID 38686016 — 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.
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