A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer
第2相
完了
NCT04699630
| 対象疾患 | Metastatic Breast Cancer, Locally Advanced Breast Cancer |
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| 相 | 第2相 |
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| スポンサー | SCRI Development Innovations, LLC |
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| ステータス | 完了 |
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| 参加者数 | 121 名 |
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| 介入（薬剤） | U3-1402 |
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| 開始日 | 2021年5月3日 |
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| 完了日 | 2025年4月9日 |
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| 結果公開日 | 2026年5月7日 |
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概要
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).
Overall Response Rate (ORR) in Participants With HER2-negative MBC (Part A and Part B)
Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months. · percentage of participants
| Part A | 35 percentage of participants |
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| Part B | 5 percentage of participants |
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Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-negative MBC (Part A and Part B)
Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months. · percentage of participants
| Part A | 43.3 percentage of participants |
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| Part B | 10.0 percentage of participants |
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