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
第3相
早期終了
NCT03439046
| 対象疾患 | Breast Cancer |
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| 相 | 第3相 |
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| スポンサー | Novartis Pharmaceuticals |
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| ステータス | 早期終了 |
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| 参加者数 | 287 名 |
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| 介入（薬剤） | Ribociclib, Letrozole, Alpelisib, Fulvestrant |
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| 開始日 | 2018年2月2日 |
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| 完了日 | 2023年12月11日 |
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| 結果公開日 | 2026年7月10日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
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