Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT07548762

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

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-04-23

258

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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) 60 50%
  • Hematological and renal function with the following parameters: White blood cell count 60 3.0 �d7 109/L; Neutrophil count 60 1.5 �d7 109/L; Platelet count 60 100 �d7 109/L; Hemoglobin 60 90 g/L; Serum creatinine C 1.5 �d7 upper limit of normal (ULN)
  • No planned breast reconstruction
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

S

Shicheng Su

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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