Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer
1/2期
进行中（已停止招募）
NCT04345913
| 适应症 | Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma |
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| 分期 | 1/2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 | 24 人 |
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| 干预（药物） | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Copanlisib Hydrochloride, Eribulin Mesylate |
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| 开始日期 | 2021年3月1日 |
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| 完成日期 | 2024年3月28日 |
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| 结果公布日 | 2025年7月28日 |
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摘要
This phase I/II trial studies the side effects and best dose of copanlisib and how well it works when given together with eribulin in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib and eribulin together may work better in treating advanced stage triple negative breast cancer compared to eribulin alone.
Maximum Tolerated Dose of Eribulin (MTD) (Phase I)
Up to 28 days · mg/m^2
| Phase I, DL and DL2 (Eribulin, Copanlisib) | 1.1 mg/m^2 |
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Recommended Phase 2 Dose of Eribulin (RP2D) (Phase I)
Up to 28 days · mg/m^2
| Phase I, DL1 (Eribulin, Copanlisib) | 1.1 mg/m^2 |
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Maximum Tolerated Dose of Copanlisib (MTD) (Phase I)
Up to 28 days · mg
| Phase I, DL and DL2 (Eribulin, Copanlisib) | 45 mg |
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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。