Recruiting

Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC

ClinicalTrials.gov IDNCT07548762

PhaseNA

Enrollment258

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Procedure: Endoscopic skin-sparing mastectomy — Endoscopic skin-sparing mastectomy (E-SSM). Under endoscopic assistance, the breast skin and partial subcutaneous tissue are preserved, while the breast parenchyma, and nipple-areola complex are resected according to oncological principles. This approach aims to maintain breast envelope integrity while ensuring oncological safety.
Procedure: Conventional mastectomy — Conventional mastectomy (CM). The breast tissue, nipple-areola complex, and a full thickness of skin and subcutaneous tissue within the traditional resection range are removed. This is the standard surgical approach for breast cancer.

Primary outcomes

Wound Complication Rate (occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively)

Eligibility information

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

Study locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510120 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.