A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
← catalyst calendarNCT06112379 · readout in 824 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,902actual
Sites
283
Countries
Australia, Austria, Belgium +23
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 | 2023-11-14 | actual | When the study began enrolling |
| Primary completion | 2028-11-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-09-23 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | 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: Pembrolizumab — also filed as KEYTRUDA®
- Drug: Doxorubicin
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Capecitabine — also filed as XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord
- Drug: Olaparib — also filed as LYNPARZA®
Primary outcome
what the primary-completion date above is the date OFEvent-free survival (EFS) in the experimental vs control arms
measured Date of randomization to date of the EFS event, up to 93 months after the first subject randomized
Publications
- PMID 39917260 — 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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