Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
3期
进行中（已停止招募）
NCT05113251
| 适应症 | Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer |
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| 分期 | 3期 |
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| 申办方 | AstraZeneca |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 927 人 |
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| 干预（药物） | Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin |
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| 开始日期 | 2021年10月25日 |
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| 完成日期 | 2025年3月12日 |
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| 结果公布日 | 2026年6月9日 |
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摘要
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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