NCT07548762 Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC
| NCT ID | NCT07548762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 258 participants in total. It began in 2025-12-05 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Shicheng Su
PRINCIPAL INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT07548762 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07548762 currently recruiting?
Yes, NCT07548762 is actively recruiting participants. Contact the research team at sushch@mail.sysu.edu.cn for enrollment information.
Where is the NCT07548762 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07548762 clinical trial?
NCT07548762 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Shicheng Su at Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 258 participants.
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