Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
4期
已完成
NCT05631795
| 适应症 | Advanced Breast Cancer |
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| 分期 | 4期 |
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| 申办方 | Novartis Pharmaceuticals |
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| 状态 | 已完成 |
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| 受试者人数 | 40 人 |
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| 干预(药物) | Alpelisib, Fulvestrant |
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| 开始日期 | 2022年8月9日 |
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| 完成日期 | 2025年6月12日 |
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| 结果公布日 | 2026年6月25日 |
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摘要
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease had progressed on or after endocrine-based treatment.
Percentage of Participants With at Least One On-treatment Adverse Events (AEs)
From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months · Percentage of participants
| Alpelisib + Fulvestrant | 100 Percentage of participants |
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