NCT07548762

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
31mo left

Started Dec 2025

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

Study Start

First participant enrolled

December 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

February 3, 2026

Last Update Submit

April 21, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Wound Complication Rate

    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%

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

Secondary Outcomes (7)

  • Patient Satisfaction

    6 months postoperatively

  • Postoperative Breast Appearance

    6 months postoperatively

  • Surgical Time

    intraoperative

  • Intraoperative Blood Loss

    intraoperative

  • Rate of Other Postoperative Adverse Complications

    up to 24 months

  • +2 more secondary outcomes

Study Arms (2)

E-SSM

EXPERIMENTAL

endoscopic skin-sparing mastectomy

Procedure: Endoscopic skin-sparing mastectomy

CM

ACTIVE COMPARATOR

conventional mastectomy

Procedure: Conventional mastectomy

Interventions

Endoscopic skin-sparing mastectomyPROCEDURE

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.

E-SSM
Conventional mastectomyPROCEDURE

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.

CM

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shicheng Su

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shicheng Su

CONTACT

+86 13631304227sushch@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

April 23, 2026

Study Start

December 5, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-01

Locations

CN(1)