Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Phase 3
Active, not recruiting
NCT05113251
| Condition | Breast Neoplasms, Breast Cancer, HER2-positive Early 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 | 927 participants |
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| Interventions | Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin |
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| Start date | Oct 25, 2021 |
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| Completion date | Mar 12, 2025 |
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| Results posted | Jun 9, 2026 |
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Summary
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Rate of Pathologic Complete Response (pCR).
Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025) · Percentage of participants
| Arm A | 43.01 Percentage of participants |
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| Arm B | 67.29 Percentage of participants |
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| Arm C | 56.25 Percentage of participants |
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| p-value | 0.001 |
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| M&N estimate of difference in rates | -13.18 (95% CI -20.84–-5.41) |
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Open in BENITIONS
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