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)
3상
진행 중(모집 완료)
NCT05104866
| 대상 질환 | Breast Cancer |
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| 임상 단계 | 3상 |
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| 스폰서 | AstraZeneca |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 732 명 |
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| 중재(약물) | Dato-DXd, Capecitabine, Gemcitabine, Eribulin, Vinorelbine |
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| 시작일 | 2021년 10월 18일 |
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| 완료일 | 2024년 7월 24일 |
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| 결과 공개일 | 2026년 2월 4일 |
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요약
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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