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

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 is testing whether a new type of breast surgery called endoscopic-assisted surgery works better than the traditional method for women with breast cancer who have already received treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1380 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06716073 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 75 with pathologically confirmed invasive breast cancer who have received preoperative chemotherapy.

Not a fit: Patients with severe comorbidities, additional malignancies, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical options and outcomes for breast cancer patients, enhancing both survival rates and quality of life.

How similar studies have performed: While similar studies have explored various surgical techniques in breast cancer treatment, this specific comparison of endoscopic-assisted versus conventional methods is relatively novel.

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).

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• 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

Conditions: Breast Cancer Invasive