Breast Cancer
Conditions
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.
Interventions
PROCEDUREEndoscopic 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.
PROCEDUREConventional 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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complication Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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. |
| Postoperative Breast Appearance | 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. |
| Surgical Time | intraoperative | Time from initial incision to completion of wound closure, measured in minutes. |
| Intraoperative Blood Loss | intraoperative | Total volume of blood lost during surgery, measured in milliliters (mL). |
| Rate of Other Postoperative Adverse Complications | 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% |
| Overall Survival (OS) | 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. |
| Disease-Free Survival (DFS) | 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. |
Countries
China
Contacts
CONTACTShicheng Su
PRINCIPAL_INVESTIGATORShicheng Su
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed