Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
← 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
557actual
Sites
208
Countries
Austria, Belgium, Canada +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 | 2018-12-27 | actual | When the study began enrolling |
| Primary completion | 2022-01-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-08-01 | estimated | The whole study's end, after follow-up |
| First posted | 2018-11-07 | actual | When this record first appeared on the registry |
| Results posted | 2023-06-15 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-06 | 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 (DS-8201a) — also filed as DS-8201a
- Drug: Capecitabine
- Drug: Eribulin
- Drug: Gemcitabine
- Drug: Paclitaxel
- Drug: Nab-paclitaxel
Primary outcome
what the primary-completion date above is the date OFProgression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
measured From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2020-10-12 · 25.9 MB · Prot_SAP_000.pdf
Publications
- PMID 35665782 — reports results
- PMID 42340017 — linked by the registry
- PMID 41062831 — linked by the registry
- PMID 40349139 — linked by the registry
- PMID 38884900 — linked by the registry
- PMID 38442809 — linked by the registry
- PMID 37597578 — linked by the registry
- PMID 37207306 — linked by the registry
- PMID 36780610 — 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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