Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
第3相
早期終了
NCT04251533
| 対象疾患 | Triple Negative Breast Neoplasms |
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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 | 137 名 |
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| 介入（薬剤） | alpelisib, nab-paclitaxel |
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| 開始日 | 2020年6月8日 |
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| 完了日 | 2023年5月31日 |
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| 結果公開日 | 2024年7月31日 |
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概要
The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months · months
| Part A: Alpelisib + Nab-paclitaxel | 7.2 months |
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| Part A: Placebo + Nab-paclitaxel | 5.6 months |
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| Hazard Ratio (HR) | 1.49 (95% CI 0.92–2.41) |
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Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1
Up to 6 months · percentage of participants
| Part B1: Alpelisib + Nab-paclitaxel | 14.3 percentage of participants |
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