DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
← catalyst calendarSponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Daiichi Sankyo Co., Ltd., AstraZeneca.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
524actual
Sites
164
Countries
Australia, Belgium, Brazil +12
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 | 2018-08-09 | actual | When the study began enrolling |
| Primary completion | 2021-05-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-30 | estimated | The whole study's end, after follow-up |
| First posted | 2018-05-18 | actual | When this record first appeared on the registry |
| Results posted | 2022-04-29 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-21 | 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: Trastuzumab deruxtecan (T-DXd) — also filed as DS-8201a
- Drug: Ado-trastuzumab emtansine (T-DM1) — also filed as T-DM1
Primary outcome
what the primary-completion date above is the date OFProgression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
measured Up to 33 months (data cut-off)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2020-09-25 · 1.5 MB · Prot_SAP_001.pdf
Publications
- PMID 38979893 — linked by the registry
- PMID 38825627 — linked by the registry
- PMID 38442809 — linked by the registry
- PMID 38059424 — linked by the registry
- PMID 37207306 — linked by the registry
- PMID 37179020 — linked by the registry
- PMID 36495879 — linked by the registry
- PMID 35964548 — linked by the registry
- PMID 35320644 — 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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