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

NCT06716073 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phase

Not applicable

Started

2024-08-01

Last updated

2024-12-04

Condition(s) studied

Breast Cancer Invasive

Investigational drug(s) / intervention(s)

Surgery

Surgery: comparison of 2 surgical procedures

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age ranging from 18 to 75 years 2. Pathologically confirmed invasive breast cancer 3. Receiving preoperative chemotherapy (Each molecular subtype corresponds to unanimous regimen) 4. cT1-3N0-3M0 5. Unilateral breast tumor 6. Eastern Cooperative Oncology Group score 0-1 7. Left Ventricular Ejection Fraction (LVEF) ≥50% 8. 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. Exclusion Criteria: 1. Diffusely disseminated malignant calcification foci 2. Not applicable for BCS after neoadjuvant therapy 3. Pregnancy or breastfeeding 4. Additional malignancy 5. 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).

Primary outcome measure(s)

5-year disease free survival — 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 — From surgery to the follow-up at 6 months
The score of Breast-Q scale "Satisfaction with breasts" table 6 months after surgery

Trial sites (2)

Facility	City	Region	Status
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital	Shantou	Guangdong	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06716073 on ClinicalTrials.gov ↗ ← All trials in China