The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,106
- 试验地点
- 2
- 主要终点
- Disease-Free Survival
研究概览
简要总结
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
详细描述
1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC)
The control group:
- If patients received BCS, WBI+Regional RT
- If patients received mastectomy, PMRT
The experimental group:
- If patients received breast conserving surgery, WBI alone
- If patients received mastectomy, No PMRT
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years or older.
- •A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
- •Patient with stage pN1 after surgery on histopathologic examination.
- •However, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes.
- •Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
- •Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
- •Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-
- •Patients who agreed to participate in the study.
排除标准
- •Patients who have received prior [neoadjuvant] chemotherapy.
- •Patients receiving radiation therapy for salvage or palliative purposes.
- •Patients with stage T
- •Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases.
- •Male breast cancer patient.
- •Patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region.
- •Patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer.
- •Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.
结局指标
主要结局
Disease-Free Survival
时间窗: 7-Year
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
次要结局
- Locoregional-Recurrence Free Survival(7-Year)
- Overall Survival(7-Year)
- Distant Metastases Free Survival(7-Year)
研究者
Kyung Hwan Shin
Professor, Chairman
Seoul National University Hospital