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Life sciences · Interventional Study
ClinicalTrials.gov · September 30, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06716073). This is a study registration, not published results. Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 804 participants (ESTIMATED). Conditions: Breast Cancer Invasive. Interventions: PROCEDURE: Surgery. Primary outcome measures: 5-year disease free survival , From surgery to the end of follow-up at 5 years; Patients' satisfaction with breast , From surgery to the follow-up at 6 months. Brief summary: 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 804 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.