Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
3期
进行中(已停止招募)
NCT02115282
| 适应症 | Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative |
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| 分期 | 3期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 608 人 |
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| 干预(药物) | Biospecimen Collection, Computed Tomography, Entinostat, Exemestane, Goserelin |
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| 开始日期 | 2014年3月29日 |
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| 完成日期 | 2020年5月5日 |
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| 结果公布日 | 2021年11月16日 |
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摘要
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Progression-free Survival (PFS)
Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression · months
| Arm A (Exemestane, Entinostat) | 3.3 months |
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| Arm B (Exemestane, Placebo) | 3.1 months |
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| p-value | 0.30 |
| Hazard Ratio (HR) | 0.87 (95% CI 0.67–1.13) |
Overall Survival (OS)
Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death · months
| Arm A (Exemestane, Entinostat) | 23.4 months |
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| Arm B (Exemestane, Placebo) | 21.7 months |
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| p-value | 0.94 |
| Hazard Ratio (HR) | 0.99 (95% CI 0.82–1.21) |
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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。