Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Фаза 3
Идёт, набор закрыт
NCT05113251
| Заболевание | Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer |
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| Фаза | Фаза 3 |
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| Спонсор | AstraZeneca |
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| Статус | Идёт, набор закрыт |
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| Участники | 927 участн. |
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| Вмешательство | Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin |
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| Дата начала | 25.10.2021 |
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| Дата завершения | 12.03.2025 |
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| Публикация результатов | 9.06.2026 |
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Кратко
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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