Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
3期
提前终止
NCT03439046
| 适应症 | Breast Cancer |
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| 分期 | 3期 |
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| 申办方 | Novartis Pharmaceuticals |
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| 状态 | 提前终止 |
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| 受试者人数 | 287 人 |
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| 干预（药物） | Ribociclib, Letrozole, Alpelisib, Fulvestrant |
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| 开始日期 | 2018年2月2日 |
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| 完成日期 | 2023年12月11日 |
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| 结果公布日 | 2026年7月10日 |
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摘要
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and, in patients with a PIK3CA mutation, on second-line treatment with alpelisib plus fulvestrant
Progression-Free Survival (PFS) by Cycle 1 Day 15 Complete Mutational Dynamic Change
Up to approximately 5.7 years · months
| Ribociclib+Letrozole (Core Phase) | 55.82 months |
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| Ribociclib+Letrozole (Core Phase) | 16.53 months |
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| Ribociclib+Letrozole (Core Phase) | 15.67 months |
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| Ribociclib+Letrozole (Core Phase) | 22.44 months |
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| Ribociclib+Letrozole (Core Phase) | 10.22 months |
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| Ribociclib+Letrozole (Core Phase) | 11.07 months |
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Number of Participants With Progression-Free Survival (PFS) Events by Cycle 1 Day 15 Complete Mutational Dynamic Change
Up to approximately 5.7 years · participants
| Ribociclib+Letrozole (Core Phase) | 31 participants |
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| Ribociclib+Letrozole (Core Phase) | 13 participants |
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| Ribociclib+Letrozole (Core Phase) | 6 participants |
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| Ribociclib+Letrozole (Core Phase) | 28 participants |
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| Ribociclib+Letrozole (Core Phase) | 6 participants |
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| Ribociclib+Letrozole (Core Phase) | 10 participants |
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Number of Participants With Hotspot Mutated Genes by Scheduled Timepoint
Up to approximately 5.7 years · participants
| Ribociclib+Letrozole (Core Phase) | 145 participants |
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| Ribociclib+Letrozole (Core Phase) | 152 participants |
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| Ribociclib+Letrozole (Core Phase) | 160 participants |
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| Ribociclib+Letrozole (Core Phase) | 147 participants |
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| Ribociclib+Letrozole (Core Phase) | 50 participants |
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| Ribociclib+Letrozole (Core Phase) | 27 participants |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。