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NCT Number: NCT07548762

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Shicheng Su

CONTACT

[email protected]

+86 13631304227

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic skin-sparing mastectomy

Procedure

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.

Conventional mastectomy

Procedure

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

  1. Wound Complication Rate

    Time frame: occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively

    Wound complications are defined as wound dehiscence requiring surgical debridement, dressing change, or packing, or persistent wound discharge, occurring prior to completion of adjuvant chemotherapy and radiotherapy. The rate is calculated as: (Number of patients with ≥1 wound complication / Total surgical patients in the group) × 100%

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 6 months postoperatively

    Breast satisfaction score from the Breast Q questionnaire at 6 months postoperatively. Patients will complete the self-reported Breast Q survey under physician guidance, which takes 1-4 minutes for the breast satisfaction module and 10-15 minutes for the full survey.

  2. Postoperative Breast Appearance

    Time frame: 6 months postoperatively

    Overall aesthetic score using the Ueda scale (0-10, 0=poor, 10=excellent) assessed by physicians, and scar appearance score using the Scar-Q scale (0-100, 4 domains) self-reported by patients, both evaluated at 6 months postoperatively.

  3. Surgical Time

    Time frame: intraoperative

    Time from initial incision to completion of wound closure, measured in minutes.

  4. Intraoperative Blood Loss

    Time frame: intraoperative

    Total volume of blood lost during surgery, measured in milliliters (mL).

  5. Rate of Other Postoperative Adverse Complications

    Time frame: up to 24 months

    Percentage of patients experiencing other postoperative complications (e.g., edema, bleeding) during the follow-up period, calculated as: (Number of patients with ≥1 other complication / Total patients in the group) × 100%

  6. Overall Survival (OS)

    Time frame: From date of surgery until the date of death from any cause, assessed up to 60 months

    Time from the date of surgery to death from any cause. Patients who remain alive will be censored at the last follow-up date.

  7. Disease-Free Survival (DFS)

    Time frame: 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.

    Defined as the time from the date of surgery to the first occurrence of any of the following events: local recurrence, regional recurrence, distant metastasis, or death from any cause. Patients without any event were censored at the last follow-up date.

Study contacts

Contact information is provided by the study sponsor or research team.

Shicheng Su

CONTACT

[email protected]

+86 13631304227

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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