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
| NCT ID | NCT06716073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Breast Cancer Invasive |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,380 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2033-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,380 participants in total. It began in 2024-08-01 with a primary completion date of 2033-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Shicheng Su, Doctor
STUDY CHAIR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT06716073 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer Invasive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716073 currently recruiting?
Yes, NCT06716073 is actively recruiting participants. Contact the research team at sushch@mail.sysu.edu.cn for enrollment information.
Where is the NCT06716073 trial being conducted?
This trial is being conducted at Guangzhou, China, Shantou, China.
Who is sponsoring the NCT06716073 clinical trial?
NCT06716073 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Shicheng Su, Doctor at Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 1,380 participants.
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