A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Residual Cancer Burden (RCB) 0/I
研究概览
简要总结
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival time, and treatment safety were subsequently evaluated.
详细描述
This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery.
After providing full informed consent and signing the informed consent form, eligible participants will enter the trial period upon screening. Within 72 hours of enrollment confirmation, participants will begin neoadjuvant therapy. Patients in the control group will receive a neoadjuvant systemic therapy regimen selected by their physician, followed by surgery and adjuvant radiotherapy. Patients in the experimental group will receive both neoadjuvant systemic therapy and neoadjuvant radiotherapy. The radiotherapy regions will include the whole breast, supraclavicular and infraclavicular areas, and internal mammary regions, with a dose of 50 Gy over 25 fractions, plus a tumor bed boost of 10-16 Gy over 4-8 fractions.
Primary Endpoint:
Residual Cancer Burden (RCB) 0/I.
Secondary Endpoints:
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years and ≤65 years；
- •newly diagnosed breast cancer;
- •Axillary lymph node biopsy-positive;
- •ECOG performance status score of 0-1;
排除标准
- •metastatic breast cancer or bilateral breast cancer;
- •inflammatory breast cancer;
- •Pregnancy and Lactation;
研究组 & 干预措施
Adjuvant radiotherapy
receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy
Neoadjuvant radiotherapy
receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery
干预措施: Neoadjuvant radiotherapy (Radiation)
结局指标
主要结局
Residual Cancer Burden (RCB) 0/I
时间窗: From enrollment to the end of treatment at 8 weeks
Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories: RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes. RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment. RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III
次要结局
- Event-Free Survival (EFS)(From enrollment to 10 years later or death.)
- Invasive Disease-Free Survival (iDFS)(From enrollment to 10 years later or death.)
- Overall Survival (OS)(From enrollment to 10 years later or death.)
- Quality of life scores(From enrollment to 3 years after treatment completion.)
- ECOG performance status scores(From enrollment to 3 years after treatment completion.)
- Surgical incision healing scores(From enrollment to 1 years after treatment completion.)
- Adverse Events (AEs)(From enrollment to 3 years after treatment completion.)