Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy

Inclusion Criteria

• •1. Age and gender: 18 to 70 years old, female;
• •2. ECOG systemic state 0\~1;
• •3. Screening examinations, including medical history, vital signs measurement, general physical examination, laboratory examinations (blood routine, urine routine, blood biochemistry, blood electrolytes, full set of pre-transfusion, etc.), electrocardiogram, heart and abdomen color Doppler ultrasound, head, chest, Abdominal CT and bone scan to determine whether the subjects are in good health and have distant metastases;
• •4. According to the RECIST1.1 standard, at least one measurable lesion exists;
• •5. Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III \[cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) standard\] Breast cancer patients;
• •6. The functional level of organs must meet the following requirements:
• •1. Blood routine ANC≥1.5×10 9/L; PLT≥90×10 9/L; Hb≥90 g/L;
• •2. Blood biochemistry TBIL≤1.5×ULN; ALT and AST≤2×ULN; BUN and Cr ≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
• •3. Heart color Doppler ultrasound LVEF≥50%;
• •4. 12-lead ECG Fridericia method corrected QT interval (QTcF) female \<470 ms.
• •7. Patients with known hormone receptor status.
• •8. Patients with negative serum pregnancy tests and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug.
• •9. During the trial period and within 6 months after the trial, female subjects should take medically acceptable or reliable contraceptive measures;
• •10. Subjects understand the test procedures, voluntarily comply with the requirements of the test protocol, and agree to participate in the test by signing an informed consent form approved by the ethics committee of the participating center.