Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early 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
Randomized · None · Treatment
Enrollment
927actual
Sites
145
Countries
Brazil, Bulgaria, 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 | 2021-10-25 | actual | When the study began enrolling |
| Primary completion | 2025-03-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-09 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-09 | 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
Conditions
- Breast Neoplasms
- Breast Cancer
- HER2-positive Early Breast Cancer
Interventions
- Drug: Trastuzumab Deruxtecan — also filed as T-DXd, Enhertu
- Drug: Paclitaxel — also filed as Taxol, Onxol
- Drug: Trastuzumab — also filed as Herceptin, Herzuma
- Drug: Pertuzumab — also filed as Perjeta
- Drug: Doxorubicin — also filed as Adriamycin, Rubex
- Drug: cyclophosphamide — also filed as Neosar, Cytoxan
Primary outcome
what the primary-completion date above is the date OFRate of Pathologic Complete Response (pCR).
measured Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-04-16 · 23.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-04-08 · 10.3 MB · SAP_001.pdf
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