Endoscopic skin-sparing versus conventional mastectomy for wound outcomes in breast cancer
A Multicenter, Randomized, Controlled, Open-Label Study Comparing Endoscopic Skin-Sparing Mastectomy With Conventional Mastectomy for Wound Complications in Patients With Breast Cancer
This trial will test whether endoscopic skin-sparing mastectomy causes fewer wound complications and improves patient satisfaction compared with conventional mastectomy in women with unilateral invasive breast cancer and small-to-moderate breasts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07548762 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label trial enrolls 258 women with unilateral invasive breast cancer (cT1-4a N0-3 M0) and randomizes them by site to endoscopic skin-sparing mastectomy (E-SSM) or conventional mastectomy (CM) without immediate reconstruction. The primary outcomes are postoperative wound complications and patient satisfaction, with secondary measures including breast appearance and oncological safety. Eligible participants must have breast volume ≤ cup C, no or mild ptosis (grade I–II), ECOG 0–1, LVEF ≥ 50% and adequate hematologic and renal function, while key exclusions include skin invasion, diffuse malignant microcalcifications, pregnancy or lactation, other primary malignancy, or severe systemic disease. Outcomes will be compared between the two surgical approaches to help guide optimal endoscopic techniques and address the evidence gap for E-SSM without immediate reconstruction.
Who should consider this trial
Good fit: Women aged 18–75 with unilateral invasive breast cancer (cT1-4a N0-3 M0), breast size ≤ cup C with no or mild ptosis, ECOG 0–1, adequate cardiac/hematologic/renal function, and no plan for immediate reconstruction are the ideal candidates.
Not a fit: Patients with tumor invasion of the skin, diffuse malignant microcalcifications, pregnancy or lactation, large breasts or marked ptosis, need for immediate reconstruction, or severe cardiopulmonary/hepatic/renal dysfunction are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, endoscopic skin-sparing mastectomy could reduce postoperative wound complications and improve cosmetic satisfaction while maintaining oncologic safety.
How similar studies have performed: Smaller series and single-center reports suggest E-SSM is feasible with acceptable oncologic outcomes and potential cosmetic advantages, but randomized evidence—particularly without immediate reconstruction—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 to 75 years * Pathologically confirmed invasive breast cancer * Clinical stage cT1-4a N0-3 M0 * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Unilateral breast cancer * Left ventricular ejection fraction (LVEF) ≥ 50% * Hematological and renal function with the following parameters: White blood cell count ≥ 3.0 × 10⁹/L; Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 × upper limit of normal (ULN) * No planned breast reconstruction Exclusion Criteria: * Tumor invasion of the skin * Diffuse malignant microcalcifications * Breast cancer during pregnancy or lactation * History of another primary malignancy * Severe cardiopulmonary, hepatic or renal dysfunction, or other significant systemic diseases
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Shicheng Su — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Shicheng Su
- Email: sushch@mail.sysu.edu.cn
- Phone: +86 13631304227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.