A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
← catalyst calendarSponsored 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
732actual
Sites
167
Countries
Argentina, Belgium, Brazil +17
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 | 2021-10-18 | actual | When the study began enrolling |
| Primary completion | 2024-07-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-03 | actual | When this record first appeared on the registry |
| Results posted | 2026-02-04 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-05 | 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: Capecitabine
- Drug: Gemcitabine
- Drug: Eribulin — also filed as Eribulin Mesylate
- Drug: Vinorelbine
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival
measured On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months
Overall Survival
measured From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-04-22 · 17.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-08-17 · 7.4 MB · SAP_001.pdf
Publications
- PMID 39265124 — linked by the registry
- PMID 37387213 — 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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