Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: A Phase III Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.
详细描述
This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed invasive breast cancer
- •Underwent neoadjuvant chemotherapy
- •Eastern Cooperative Oncology Group Performance Status Scale 0-2
- •ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy
- •No distant metastases
- •No internal mammary nodes metastases based on images before system therapy
- •Willing to follow up
- •Written,informed consent
排除标准
- •Without neoadjuvant chemotherapy
- •Distant metastases
- •Simultaneous bilateral breast cancer
- •Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy
- •Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
结局指标
主要结局
Disease free survival
时间窗: 5 years
From date of enrollment until to the first recurrence in the ipsilateral breast or chestwall, the regional nodal area, or a distant site or death due to any cause
次要结局
- Overall survival(5 years)
- Distant metastasis-free survival(5 years)
- Local-regional recurrence-free survival(5 years)
研究者
Yong Yang
M.D.
Fujian Medical University Union Hospital