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The trial that got Datroway approved in hormone-positive breast cancer, though it did not extend overall survival.
TROPION-Breast01, trial NCT05104866 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, is the trial that got datopotamab deruxtecan approved in HR-positive, HER2-negative metastatic breast cancer after endocrine therapy and one or two chemotherapies, though it did not extend overall survival. It randomised 732 patients to datopotamab deruxtecan or chemotherapy, met its primary progression-free survival endpoint with a higher response rate, but overall survival, also a primary endpoint, was no different, and the US approval in January 2025 rested on progression alone. OnCo links it to HR-positive breast cancer, datopotamab deruxtecan, Aditya Bardia, Sara M. Tolaney, the TROP2 ADC roadmap and the TROPION-Breast01 paper on why a progression win did not translate to survival. Why the two TROP2 ADCs diverged on survival is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
732 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Datopotamab deruxtecan | 365 | 6.9 months | 0.63 (0.52 to 0.76) | <0.0001 | link |
| Chemotherapy (ICC) | 367 | 4.9 months | ||||
| Overall survivalprimary | Datopotamab deruxtecan | - | 18.6 months | 1.01 (0.83 to 1.22) | - | link |
| Chemotherapy (ICC) | - | 18.3 months | ||||
| Objective response rate | Datopotamab deruxtecan | - | 36.4% | - | - | link |
| Chemotherapy (ICC) | - | 22.9% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Chinese patients in the trial saw the same pattern as the global population: a clear progression-free survival gain, no proven survival gain, and a different rather than heavier side-effect burden, with mouth and eye toxicity in nearly half. It supports use of datopotamab deruxtecan in this setting in China but does not resolve the global trial's missing survival benefit.
For unresectable or metastatic hormone-receptor-positive, HER2-negative breast cancer after endocrine-based therapy and chemotherapy for advanced disease, Dato-DXd is an FDA-approved option. TROPION-Breast01 showed longer progression-free survival and fewer severe treatment-related adverse events than chemotherapy; the final overall survival analysis did not show a statistically significant improvement. Approval in this setting does not establish a survival advantage or apply to postoperative early-stage disease.
Shares TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo.
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo, Progression-free survival (PFS).
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads).
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Datopotamab deruxtecan, Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo, Progression-free survival (PFS).
Shares Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca, Antibody-drug conjugate (ADC).
Shares Sara M. Tolaney, Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/