Breast Cancer Invasive
Conditions
Brief summary
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
PROCEDURESurgery
comparison of 2 surgical procedures
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
1. Age ranging from 18 to 75 years 2. Pathologically confirmed invasive breast cancer 3. Receiving preoperative chemotherapy (Each molecular subtype corresponds to unanimous regimen) 4. cT1-3N0-3M0 5. Unilateral breast tumor 6. Eastern Cooperative Oncology Group score 0-1 7. Left Ventricular Ejection Fraction (LVEF) ≥50% 8. 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
1. Diffusely disseminated malignant calcification foci 2. Not applicable for BCS after neoadjuvant therapy 3. Pregnancy or breastfeeding 4. Additional malignancy 5. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease free survival | From surgery to the end of follow-up at 5 years | The proportion of patients remaining after excluding patients with disease recurrence, metastasis or death from the time of surgery to 5-year follow-up |
| Patients' satisfaction with breast | From surgery to the follow-up at 6 months | The score of Breast-Q scale Satisfaction with breasts table 6 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeons' satisfaction with breast | From surgery to the follow-up at 6 months | Surgeons evaluate the cosmetic outcome of breast based on the photos before surgery and after surgery. Four ranks: Excellent (9-10 points), Good (7-8 points), Fair (5-6 points) and Poor (0-4 points) are categorized on a basis of average total score from Ueda scale |
| Patients satisfaction with scar | From surgery to the follow-up at 6 months | Scar-Q scale including 3 tables about the surgical scar: appearance, symptom, psychosocial impact with total score of 100 will be used for evaluating patients satisfaction with scar |
| 5-year overall survival | From surgery to the end of follow-up at 5 years | The proportion of patients remaining after excluding patients who died from any cause at 5-year follow-up |
| 5-year local-regional recurrence rate | From surgery to the end of follow-up at 5 years | The proportion of patients with a lump found on breast, axilla, chest wall, skin or scars of surgery ipsilateral to the surgical side through physical examination or imaging, confirmed as the same pathological type as the primary tumor according to biopsy at 5-year follow up |
| Postoperative complication rate | From surgery to the follow-up at 12 months | The proportion of patients with postoperative complications including hemorrhage, incision dehiscence, upper limb lymphedema, infection,seroma. |
| Surgical duration | Intraoperative | The time from the beginning of surgery to the end of surgery |
| Intraoperative blood loss | Intraoperative | The blood loss during the operation |
| Incision length | Intraoperative | The length of surgical incision |
Countries
China
Contacts
Primary ContactShicheng Su
Backup ContactYiwen Lu, Doctor
Outcome results
None listed