Postmastectomy Prophylactic Internal Mammary Nodal Irradiation for High-risk Patients With Non-metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy or breast-conserving surgery.
详细描述
Eligible patients are randomized into 2 groups: chest wall/whole breast and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall/whole breast and supraclavicular nodal +-axillary nodal irradiation. The prescription dose is 50 Gy in 25 fractions over 5 weeks or 43.5Gy in 15 fractions over 3 weeks. Breast cancer patients treated with breast-conserving surgery will receive tumor bed boost.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group Performance Status Scale 0-2
- •Histologically confirmed invasive breast cancer
- •Underwent total mastectomy/breast-conserving surgery and axillary dissection(10 or more axillary lymph nodes detected) and negative margins
- •Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1， IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy
- •No supraclavicular or internal mammary nodes metastases based on images before system therapy
- •No distant metastases
- •Could tolerate radiotherapy
- •Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles)
- •Anticipated to receive endocrine therapy for 5 years if indicated
- •Anticipated to receive anti-HER2 therapy for 1 years if indicated
- •LVEF≥50% based on echocardiogram
- •Willing to follow up
- •Written,informed consent
排除标准
- •Simultaneous bilateral breast cancer
- •Sentinel lymph node biopsy only without axillary dissection
- •Had received internal mammary node dissection
- •No imaging assessment of the internal mammary nodal before system therapy
- •One-stage breast reconstruction
- •Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease
- •Had history of chest wall or supraclavicular radiotherapy
- •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
研究组 & 干预措施
internal mammary nodal irradiation
chest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
干预措施: internal mammary nodal irradiation (Radiation)
no-internal mammary nodal irradiation
ipsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation
干预措施: no internal mammary nodal irradiation (Radiation)
结局指标
主要结局
disease-free survival
时间窗: 5 years
failure: relapse of ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal or distant metastasis or contralateral invasive breast cancer or death due to any cause.
次要结局
- overall survival(5 years)
- cumulative internal mammary nodal recurrence(5 years)
- cumulative locoregional recurrence(5 years)
- distant metastasis(5 years)
- contralateral non-invasive breast cancer or other malignant tumors(5 years)
- major cardiovascular events(5 years)
- quality of life(5 years)
- incidence of adverse events(5 years)
研究者
Shulian Wang
Clinical professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences