jRCT2041210097进行中（未招募）不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
- 主要终点
- rate of pathologic complete response (pCR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 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
结局指标
主要结局
rate of pathologic complete response (pCR)
时间窗: Following completion of neoadjuvant therapy
Proportion of participants who have no evidence by H&E staining of residual invasive disease
次要结局
未报告次要终点
研究者
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