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.
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
Tumor invasion of the skin
Diffuse malignant microcalcifications
Breast cancer during pregnancy or lactation
History of another primary malignancy