A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
506actual
Sites
81
Countries
Australia, Belgium, Canada +15
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 | 2021-06-22 | actual | When the study began enrolling |
| Primary completion | 2024-02-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-05-26 | estimated | The whole study's end, after follow-up |
| First posted | 2021-02-05 | actual | When this record first appeared on the registry |
| Results posted | 2025-05-16 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-11 | 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
Intervention
- Drug: Trastuzumab Deruxtecan — also filed as fam-trastuzumab deruxtecan-nxki
Primary outcomes
what the primary-completion date above is the date OFObjective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline)
measured From first dose (Day 1) to progression of disease (up to 2 years 7 months)
Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline)
measured At 12 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-06-07 · 1.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-12-07 · 6.9 MB · SAP_001.pdf
Publications
- PMID 39271844 — 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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