A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
3期
进行中（已停止招募）
NCT04739761
| 适应症 | 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 | 506 人 |
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| 干预（药物） | Trastuzumab Deruxtecan |
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| 开始日期 | 2021年6月22日 |
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| 完成日期 | 2024年2月8日 |
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| 结果公布日 | 2025年5月16日 |
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摘要
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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