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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1,380 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,380

Conditions

Breast Cancer Invasive

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

5-year disease free survival

The proportion of patients remaining after excluding patients with disease recurrence, metastasis or death from the time of surgery to 5-year follow-up

Time frame: From surgery to the end of follow-up at 5 years

Patients' satisfaction with breast

The score of Breast-Q scale "Satisfaction with breasts" table 6 months after surgery

Time frame: From surgery to the follow-up at 6 months

Secondary Outcomes

Surgeons' satisfaction with breast

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

Time frame: From surgery to the follow-up at 6 months

Patients satisfaction with scar

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

Time frame: From surgery to the follow-up at 6 months

5-year overall survival

The proportion of patients remaining after excluding patients who died from any cause at 5-year follow-up

Time frame: From surgery to the end of follow-up at 5 years

5-year local-regional recurrence rate

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

Time frame: From surgery to the end of follow-up at 5 years

Postoperative complication rate

The proportion of patients with postoperative complications including hemorrhage, incision dehiscence, upper limb lymphedema, infection,seroma.

Time frame: From surgery to the follow-up at 12 months

Surgical duration

The time from the beginning of surgery to the end of surgery

Time frame: Intraoperative

Intraoperative blood loss

The blood loss during the operation

Time frame: Intraoperative

Incision length

The length of surgical incision

Time frame: Intraoperative

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts