A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
Phase 1
Active, not recruiting
NCT04288089
| Condition | Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms |
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| Phase | Phase 1 |
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| Sponsor | Eisai Inc. |
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| Status | Active, not recruiting |
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| Enrollment | 31 participants |
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| Interventions | Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg) |
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| Start date | Apr 1, 2020 |
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| Completion date | Sep 16, 2022 |
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| Results posted | Mar 22, 2024 |
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Summary
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.
Maximum Tolerated Dose (MTD) of H3B-6545 and Palbociclib
Cycle 1 (Cycle length = 28 Days) · milligram
| All Participants | 125 milligram |
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| All Participants | 300 milligram |
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Open in BENITIONS
View on ClinicalTrials.gov
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