JPRN-jRCT2041210097招募中3 期
A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)
Inoguchi Akihiro0 个研究点目标入组 900 人开始时间: 2021年11月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •- Patients must be at least 18 years of age.
- •- Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment):
- •T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or >= T3, N0, M0 as determined by the AJCC staging system, 8th edition
- •- ECOG performance status of 0 or 1 at randomization
排除标准
- •Exclusion Criteria:
- •- prior history of invasive breast cancer
- •- stage IV breast cancer (determined by AJCC staging system)
- •- any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease). This includes a second current breast primary malignancy (ie, bilateral breast cancer).
- •- history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)
- •- History of, or current, ILD/pneumonitis
- •- Prior systemic therapy for the treatment of breast cancer
- •- Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy
研究者
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