Breast cancer
Conditions
Interventions
NAAS group:Do not perform axillary lymph node dissection (ALND) in NAAS node-negative patients
ALND group:Perform axillary lymph node dissection (ALND) in NAAS node-negative patients
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women =18 years of age at diagnosis; 2. Invasive breast cancer was confirmed by ultrasound-guided core needle biopsy; 3. Neoadjuvant chemotherapy according to the existing guidelines; 4. No co-occurring malignant tumors (except controlled cervical carcinoma in situ and skin basal cell carcinoma); 5. Normal bone marrow function, blood routine: neutrophil =2.5×10^9/L, hemoglobin =100g/L, platelet =100×10^9/L, no coagulation dysfunction; 6. Normal liver and kidney function :AST=60U/L, serum total bilirubin =1.5 times upper limit of normal, serum creatinine =110umol/L, serum urea nitrogen =7.1mmol/L; 7. Electrocardiogram was basically normal, and echocardiography showed left ventricular ejection fraction =55%. 8. ECOG score 0-2; 9. Willing to cooperate in postoperative chemotherapy and related treatment; 10. The informed consent was signed and the protocol compliance was good.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis of breast cancer has been found; 2. Inflammatory breast cancer before neoadjuvant chemotherapy; 3. Have a history of axillary surgery (including SLNB, bromhidrosis surgery, etc.); 4. Pregnant or lactating patients; 5. Patients who cannot tolerate neoadjuvant chemotherapy and related treatment; 6. Patients with uncontrolled pulmonary diseases, severe infections, active gastrointestinal ulcers requiring treatment, coagulation disorders, connective tissue diseases or bone marrow suppression; 7. Previous congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, refractory hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 100mmHg); 8. Patients with mental illness or other reasons who cannot comply with treatment; 9. Known history of severe allergy to any of the drugs in the regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year and 5-year axillary recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year and 5-year recurrence free survival (RFS);2-year and 5-year disease-free survival (DFS);2-year and 5-year overall survival (OS);Breast cancer-related quality of life at 2 and 5 years;Postoperative upper limb function and incidence of complications;Postoperative complications;Perioperative indicators; | — |
Countries
China
Contacts
Public ContactJie Chen
West China Hospital of Sichuan University
Outcome results
None listed