A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
Phase 3
Active, not recruiting
NCT04739761
| Condition | Breast Cancer |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 506 participants |
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| Interventions | Trastuzumab Deruxtecan |
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| Start date | Jun 22, 2021 |
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| Completion date | Feb 8, 2024 |
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| Results posted | May 16, 2025 |
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Summary
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline)
From first dose (Day 1) to progression of disease (up to 2 years 7 months) · Percentage of participants
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | 62.7 Percentage of participants |
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Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline)
At 12 months · Percentage of participants
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | 61.6 Percentage of participants |
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Open in BENITIONS
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