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Recruiting NCT06716073

Long-Term Outcomes of Endoscopic-assisted vs Conventional Breast-conserving Surgery in Breast Cancer Patients After Neoadjuvant Therapy: a Randomized, Multicenter, Open Label, Non-inferiority Trial

No phase Interventional Breast Cancer Invasive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery.
Who it may be relevant to
Registry conditions: Breast Cancer Invasive. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

With the title of "Long-Term Outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial", this study targets breast cancer patients after neoadjuvant therapy. A total of 1380 eligible patients, after screening with inclusion and exclusion criteria, will be randomly assigned to Endoscopic-assisted breast conserving surgery(E-BCS) or conventional breast conserving surgery (C-BCS) group at a 1:1 ratio using stratified block randomization method, stratified by centers and molecular subtype. The co-primary endpoints are 5-year disease-free survival (5y-DFS) and Breast-Q score at 6 months after surgery. The secondary endpoints are cosmetic outcomes including surgeons' satisfaction with breast and patients' satisfaction with scar, survival outcomes including 5-year overall survival (5y-OS) and 5-year local-recurrence rate (5y-LRR), surgical outcomes including operative time, intraoperative blood loss, incision length and postoperative complications rate. This study aims to confirm the long-term safety and aesthetic outcome of endoscopic-assisted surgery in breast cancer patients after neoadjuvant treatment by comparing it with conventional open breast conserving surgery, and provide clinical evidence for the popularized application of endoscopic breast surgery.

Interventions

  • Procedure Surgery
    comparison of 2 surgical procedures

Primary outcome measures

  • 5-year disease free survival [Time frame: From surgery to the end of follow-up at 5 years]
  • Patients' satisfaction with breast [Time frame: From surgery to the follow-up at 6 months]
Secondary outcome measures (8)
  • Surgeons' satisfaction with breast [Time frame: From surgery to the follow-up at 6 months]
  • Patients satisfaction with scar [Time frame: From surgery to the follow-up at 6 months]
  • 5-year overall survival [Time frame: From surgery to the end of follow-up at 5 years]
  • 5-year local-regional recurrence rate [Time frame: From surgery to the end of follow-up at 5 years]
  • Postoperative complication rate [Time frame: From surgery to the follow-up at 12 months]
  • Surgical duration [Time frame: Intraoperative]
  • Intraoperative blood loss [Time frame: Intraoperative]
  • Incision length [Time frame: Intraoperative]

Eligibility criteria

Inclusion criteria

  • Age ranging from 18 to 75 years
  • Pathologically confirmed invasive breast cancer
  • Receiving preoperative chemotherapy (Each molecular subtype corresponds to unanimous regimen)
  • cT1-3N0-3M0
  • Unilateral breast tumor
  • Eastern Cooperative Oncology Group score 0-1
  • Left Ventricular Ejection Fraction (LVEF) ≥50%
  • Leukocytes ≥ 3.0×109/L, Absolute neutrophil count ≥ 1.5×109/L, Platelets ≥ 100×109/L, Hemoglobin ≥ 90g/L, Creatinine <1.5 × institutional ULN, Total bilirubin ≤ 2.0 × institutional ULN.

Exclusion criteria

  • Diffusely disseminated malignant calcification foci
  • Not applicable for BCS after neoadjuvant therapy
  • Pregnancy or breastfeeding
  • Additional malignancy
  • Severe cardiopulmonary, liver or kidney dysfunction or other systemic diseases (such as uncontrolled chronic heart failure, critical hypertension or diabetes with poor blood glucose control).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital — Shantou

Identifiers

NCT: NCT06716073 · SYSKY-2024-648-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗