A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
← catalyst calendarSponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca, NSABP Foundation Inc, GBG Forschungs GmbH, Spanish Breast Cancer Research Group (SOLTI).
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,600estimated
Sites
482
Countries
Argentina, Australia, Belgium +28
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 | 2020-12-04 | actual | When the study began enrolling |
| Primary completion | 2025-07-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-20 | estimated | The whole study's end, after follow-up |
| First posted | 2020-11-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- HER2-Positive Primary Breast Cancer
- Residual Invasive Breast Cancer
Interventions
- Drug: DS-8201a — also filed as Trastuzumab deruxtecan (T-DXd)
- Drug: T-DM1 — also filed as Trastuzumab emtansine (T-DM1)
Primary outcome
what the primary-completion date above is the date OFInvasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
measured Randomization to date of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first), up to approximately 57 months postdose
Publications
- PMID 41370739 — linked by the registry
- PMID 40073831 — 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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