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 | Recruiting

• 1 other identifier: SYSKY-2024-648-01
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (2)

• 5-year disease free survival

  The proportion of patients remaining after excluding patients with disease recurrence, metastasis or death from the time of surgery to 5-year follow-up

  From surgery to the end of follow-up at 5 years

• Patients' satisfaction with breast

  The score of Breast-Q scale "Satisfaction with breasts" table 6 months after surgery

  From surgery to the follow-up at 6 months

Secondary Outcomes (8)

• Surgeons' satisfaction with breast

  From surgery to the follow-up at 6 months

• Patients satisfaction with scar

  From surgery to the follow-up at 6 months

• 5-year overall survival

  From surgery to the end of follow-up at 5 years

• 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

Study Arms (2)

Endoscopic breast-conserving surgery (E-BCS) group

EXPERIMENTAL

Procedure: Surgery

Conventional breast-conserving surgery (C-BCS) group

NO INTERVENTION

Interventions

Surgery PROCEDURE

comparison of 2 surgical procedures

Endoscopic breast-conserving surgery (E-BCS) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (2)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital

Shantou, Guangdong, China

NOT YET RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Shicheng Su, Doctor

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

  STUDY CHAIR

Central Study Contacts

Shicheng Su

CONTACT

+86-13631304227; sushch@mail.sysu.edu.cn

Yiwen Lu, Doctor

CONTACT

+86-13268121885; luyw8@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)