Long-Term Outcomes of Endoscopic-assisted vs Conventional Breast-conserving Surgery in Breast Cancer Patients After Neoadjuvant Therapy: a Randomized, Multicenter, Open Label, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,380
- 试验地点
- 2
- 主要终点
- 5-year disease free survival
研究概览
简要总结
With the title of "Long-Term Outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial", this study targets breast cancer patients after neoadjuvant therapy. A total of 1380 eligible patients, after screening with inclusion and exclusion criteria, will be randomly assigned to Endoscopic-assisted breast conserving surgery(E-BCS) or conventional breast conserving surgery (C-BCS) group at a 1:1 ratio using stratified block randomization method, stratified by centers and molecular subtype. The co-primary endpoints are 5-year disease-free survival (5y-DFS) and Breast-Q score at 6 months after surgery. The secondary endpoints are cosmetic outcomes including surgeons' satisfaction with breast and patients' satisfaction with scar, survival outcomes including 5-year overall survival (5y-OS) and 5-year local-recurrence rate (5y-LRR), surgical outcomes including operative time, intraoperative blood loss, incision length and postoperative complications rate. This study aims to confirm the long-term safety and aesthetic outcome of endoscopic-assisted surgery in breast cancer patients after neoadjuvant treatment by comparing it with conventional open breast conserving surgery, and provide clinical evidence for the popularized application of endoscopic breast surgery.
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
- 否
入选标准
- •Age ranging from 18 to 75 years
- •Pathologically confirmed invasive breast cancer
- •Receiving preoperative chemotherapy (Each molecular subtype corresponds to unanimous regimen)
- •cT1-3N0-3M0
- •Unilateral breast tumor
- •Eastern Cooperative Oncology Group score 0-1
- •Left Ventricular Ejection Fraction (LVEF) ≥50%
- •Leukocytes ≥ 3.0×109/L, Absolute neutrophil count ≥ 1.5×109/L, Platelets ≥ 100×109/L, Hemoglobin ≥ 90g/L, Creatinine <1.5 × institutional ULN, Total bilirubin ≤ 2.0 × institutional ULN.
排除标准
- •Diffusely disseminated malignant calcification foci
- •Not applicable for BCS after neoadjuvant therapy
- •Pregnancy or breastfeeding
- •Additional malignancy
- •Severe cardiopulmonary, liver or kidney dysfunction or other systemic diseases (such as uncontrolled chronic heart failure, critical hypertension or diabetes with poor blood glucose control).
研究组 & 干预措施
Conventional breast-conserving surgery (C-BCS) group
Endoscopic breast-conserving surgery (E-BCS) group
干预措施: Surgery (Procedure)
结局指标
主要结局
5-year disease free survival
时间窗: From surgery to the end of follow-up at 5 years
The proportion of patients remaining after excluding patients with disease recurrence, metastasis or death from the time of surgery to 5-year follow-up
Patients' satisfaction with breast
时间窗: From surgery to the follow-up at 6 months
The score of Breast-Q scale "Satisfaction with breasts" table 6 months after surgery
次要结局
- Surgical duration(Intraoperative)
- Surgeons' satisfaction with breast(From surgery to the follow-up at 6 months)
- 5-year overall survival(From surgery to the end of follow-up at 5 years)
- Patients satisfaction with scar(From surgery to the follow-up at 6 months)
- 5-year local-regional recurrence rate(From surgery to the end of follow-up at 5 years)
- Postoperative complication rate(From surgery to the follow-up at 12 months)
- Intraoperative blood loss(Intraoperative)
- Incision length(Intraoperative)