Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer
第1/2相
実施中（募集終了）
NCT04345913
| 対象疾患 | 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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| 相 | 第1/2相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 24 名 |
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| 介入（薬剤） | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Copanlisib Hydrochloride, Eribulin Mesylate |
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| 開始日 | 2021年3月1日 |
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| 完了日 | 2024年3月28日 |
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| 結果公開日 | 2025年7月28日 |
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概要
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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