Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
866actual
Sites
293
Countries
Argentina, Australia, Austria +25
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 | 2020-07-24 | actual | When the study began enrolling |
| Primary completion | 2024-03-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-19 | estimated | The whole study's end, after follow-up |
| First posted | 2020-07-31 | actual | When this record first appeared on the registry |
| Results posted | 2025-04-02 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced or Metastatic Breast Cancer
Interventions
- Drug: Trastuzumab deruxtecan — also filed as DS-8201a; T-DXd
- Drug: Capecitabine
- Drug: Paclitaxel
- Drug: Nab-Paclitaxel
Primary outcome
what the primary-completion date above is the date OFProgression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population
measured Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-05-23 · 2.7 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-03-20 · 1.3 MB · SAP_003.pdf
Publications
- PMID 39282896 — linked by the registry
- PMID 37499870 — 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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