Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer

Inclusion Criteria: 1. Women aged ≥18 years and ≤75 years who are newly treated for breast cancer; 2. Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH 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. ECOG 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: ANC ≥1.5×109/L; PLT ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: TBIL≤ upper limit of normal value (ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault 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, they should consent to abstinence or use 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. Exclusion Criteria: 1. Known allergic history of the drug components of this protocol; 2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma); 3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery; 4. Stage IV (metastatic) breast cancer patients; 5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 6. Serious heart disease or discomfort that cannot be treated; 7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 8. Pregnant or lactating women; 9. Patients with severe liver and kidney function diseases and blood system diseases; 10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Poor compliance and refusal to cooperate with treatment