A Phase III Prospective Randomized Study of Elective Regional Lymph Node Irradiation in Pathologic N1 Breast Cancer Patients Treated With Breast Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 827
- 试验地点
- 2
- 主要终点
- Disease-free survival
研究概览
简要总结
This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).
详细描述
Objective:
- Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy.
- Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.
- Compare the treatment-related toxicities between the WBI and WB+RNI.
- Compare the patient's quality of life between the WBI and WB+RNI.
Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy [SLN] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive WB+RNI.
- Arm II: Patients receive WBI alone.
Arm circumference and quality of life (EORTC QLQ-C30 & EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven invasive carcinoma of the breast.
- •One to three positive axillary lymph nodes (pN1) proven in pathologic specimen.
- •Prior breast-conserving surgery and post-operative adjuvant chemotherapy including taxane.
- •Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.
- •Administering anti-HER2 therapy in cases with HER2-positive tumor.
排除标准
- •Metastases in supraclavicular or internal mammary lymph nodes.
- •Metastases in distant organs.
- •Neoadjuvant chemotherapy or hormone therapy before surgery.
- •Not receiving adjuvant anthracycline and taxane.
- •Bilateral breast cancer
- •Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph nodes.
- •Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of the cervix, or skin cancer.
结局指标
主要结局
Disease-free survival
时间窗: 7 years
Disease-free survival
次要结局
- Treatment-related toxicity(5 years)
- European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement(5 years)
- Disease-free survival according to molecular subtype(5 years)
- EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement(5 years)