Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC
Recruiting · NCT07548762 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The primary objective is to evaluate differences in postoperative wound complications and patient satisfaction, with secondary outcomes including breast appearance and oncological safety. Eligible patients have a breast volume ≤ cup C and no/mild ptosis (grade I-II). A total of 258 participants (129 per group) will be enrolled across multiple centers and randomized by site. This study aims to provide evidence for selecting optimal endoscopic surgical strategies, address the evidence gap for E-SSM without immediate reconstruction, and advance the precision of breast cancer surgery.
Who can take part
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 is running
1 location listed.
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University - Guangzhou, Guangdong, China