NCT06716073

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,380 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Breast Cancer Invasive

Interventions

Type	Name	Description
PROCEDURE	Surgery	comparison of 2 surgical procedures

Timeline

• Start date: 2024-08-01
• Primary completion: 2033-01-01
• Completion: 2033-01-01
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

2 sites across 1 country: China