A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
Phase 3
Active, not recruiting
NCT05104866
| Condition | Breast Cancer |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 732 participants |
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| Interventions | Dato-DXd, Capecitabine, Gemcitabine, Eribulin, Vinorelbine |
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| Start date | Oct 18, 2021 |
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| Completion date | Jul 24, 2024 |
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| Results posted | Feb 4, 2026 |
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Summary
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.
Progression-Free Survival
On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months · Months
| Dato-DXd | 6.9 Months |
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| Investigator's Choice of Chemotherapy (ICC) | 4.9 Months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.63 (95% CI 0.49–0.80) |
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Overall Survival
From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. · Months
| Dato-DXd | 18.6 Months |
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| Investigator's Choice of Chemotherapy (ICC) | 18.3 Months |
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| p-value | 0.9445 |
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| Hazard Ratio (HR) | 1.01 (95% CI 0.83–1.23) |
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Open in BENITIONS
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