Endoscopic skin-sparing versus conventional mastectomy for wound outcomes in breast cancer

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.