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)
3期
进行中（已停止招募）
NCT05104866
| 适应症 | Breast Cancer |
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| 分期 | 3期 |
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| 申办方 | AstraZeneca |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 732 人 |
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| 干预（药物） | Dato-DXd, Capecitabine, Gemcitabine, Eribulin, Vinorelbine |
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| 开始日期 | 2021年10月18日 |
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| 完成日期 | 2024年7月24日 |
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| 结果公布日 | 2026年2月4日 |
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摘要
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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