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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Invasive
• Intervention / Treatment: Procedure: Surgery

• Study Type: Interventional
• Enrollment (Estimated): 1380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shicheng Su; Phone Number: +86-13631304227; Email: sushch@mail.sysu.edu.cn
• Study Contact Backup: Name: Yiwen Lu, Doctor; Phone Number: +86-13268121885; Email: luyw8@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Shicheng Su; Phone Number: +86-13631304227; Email: sushch@mail.sysu.edu.cn
    • Shantou, Guangdong, China
      • Not yet recruiting
      • Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital
      • Contact: Yandan Yao; Phone Number: +86-13826292688; Email: yaoyand@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic breast-conserving surgery (E-BCS) group	Procedure: Surgery; comparison of 2 surgical procedures
No Intervention: Conventional breast-conserving surgery (C-BCS) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeons' satisfaction with breast	Surgeons evaluate the cosmetic outcome of breast based on the photos before surgery and after surgery. Four ranks: Excellent (9-10 points), Good (7-8 points), Fair (5-6 points) and Poor (0-4 points) are categorized on a basis of average total score from Ueda scale	From surgery to the follow-up at 6 months
Patients satisfaction with scar	Scar-Q scale including 3 tables about the surgical scar: appearance, symptom, psychosocial impact with total score of 100 will be used for evaluating patients satisfaction with scar	From surgery to the follow-up at 6 months
5-year overall survival	The proportion of patients remaining after excluding patients who died from any cause at 5-year follow-up	From surgery to the end of follow-up at 5 years
5-year local-regional recurrence rate	The proportion of patients with a lump found on breast, axilla, chest wall, skin or scars of surgery ipsilateral to the surgical side through physical examination or imaging, confirmed as the same pathological type as the primary tumor according to biopsy at 5-year follow up	From surgery to the end of follow-up at 5 years
Postoperative complication rate	The proportion of patients with postoperative complications including hemorrhage, incision dehiscence, upper limb lymphedema, infection,seroma.	From surgery to the follow-up at 12 months
Surgical duration	The time from the beginning of surgery to the end of surgery	Intraoperative
Intraoperative blood loss	The blood loss during the operation	Intraoperative
Incision length	The length of surgical incision	Intraoperative

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Chair: Shicheng Su, Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSKY-2024-648-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No