A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer
Phase 2
Completed
NCT04699630
| Condition | Metastatic Breast Cancer, Locally Advanced Breast Cancer |
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| Phase | Phase 2 |
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| Sponsor | SCRI Development Innovations, LLC |
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| Status | Completed |
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| Enrollment | 121 participants |
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| Interventions | U3-1402 |
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| Start date | May 3, 2021 |
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| Completion date | Apr 9, 2025 |
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| Results posted | May 7, 2026 |
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Summary
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).
Overall Response Rate (ORR) in Participants With HER2-negative MBC (Part A and Part B)
Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months. · percentage of participants
| Part A | 35 percentage of participants |
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| Part B | 5 percentage of participants |
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Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-negative MBC (Part A and Part B)
Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months. · percentage of participants
| Part A | 43.3 percentage of participants |
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| Part B | 10.0 percentage of participants |
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