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

Официальное название

A Multicenter, Randomized, Controlled, Open-Label Study Comparing Endoscopic Skin-Sparing Mastectomy With Conventional Mastectomy for Wound Complications in Patients With Breast Cancer

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Wound Complication Rate [Срок оценки: occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively]

Вторичные конечные точки (7)

• Patient Satisfaction [Срок оценки: 6 months postoperatively]
• Postoperative Breast Appearance [Срок оценки: 6 months postoperatively]
• Surgical Time [Срок оценки: intraoperative]
• Intraoperative Blood Loss [Срок оценки: intraoperative]
• Rate of Other Postoperative Adverse Complications [Срок оценки: up to 24 months]
• Overall Survival (OS) [Срок оценки: From date of surgery until the date of death from any cause, assessed up to 60 months]
• Disease-Free Survival (DFS) [Срок оценки: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07548762 · SYSKY-2025-809-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗