Comparing endoscopic-assisted and conventional breast-conserving surgery for breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the long-term outcomes of endoscopic-assisted breast-conserving surgery (E-BCS) versus conventional breast-conserving surgery (C-BCS) in patients with invasive breast cancer who have undergone neoadjuvant therapy. A total of 1380 eligible participants will be randomly assigned to either surgical approach, with the primary endpoints being 5-year disease-free survival and patient-reported satisfaction scores. Secondary endpoints include cosmetic outcomes, overall survival, and local recurrence rates, providing a comprehensive assessment of both surgical techniques.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital
  Shantou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Shicheng Su
• Email: sushch@mail.sysu.edu.cn
• Phone: +86-13631304227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.