Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer
Phase 1/2
Active, not recruiting
NCT04345913
| Condition | 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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| Phase | Phase 1/2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 24 participants |
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| Interventions | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Copanlisib Hydrochloride, Eribulin Mesylate |
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| Start date | Mar 1, 2021 |
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| Completion date | Mar 28, 2024 |
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| Results posted | Jul 28, 2025 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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