Pyrotinib in HER2-positive Early Breast Cancer

Inclusion Criteria

• •1. Women aged ≥18 years and ≤75 years with newly treated breast cancer;
• •2. Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive);
• •3. Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
• •4. Eastern Cooperative Oncology Group score 0\~1;
• •5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
• •6. If the major organs function normally, the following criteria are met:
• •(1) The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent.