Clinical Research Directory

Inclusion Criteria: 1. Age: 18-70 years; 2. Clinical T2-T4d, or T1c with axillary lymph node positivity; 3. Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay； 4. Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization; 5. No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy: 1. Neutrophil count absolute value ≧2.0×109/L; 2. Hemoglobin ≧ 100g/L; 3. Platelet count ≧100×109/L; 4. Total bilirubin \<1.5 ULN (upper limit of normal); 5. Creatinine \< 1.5×ULN 6. AST/ALT \< 1.5×ULN; 6. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%); 7. Reproductive age women, negative serum pregnancy test within 14 days before randomization; 8. ECOG score 0 or 1; 9. Signature of informed consent. Exclusion Criteria: 1. Stage IV (metastatic) breast cancer; 2. Bilateral breast cancer; 3. Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease; 4. Patients with a second primary malignancy, except for adequately treated skin cancer; 5. Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures; 6. Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following: 1. History of heart failure or systolic dysfunction (LVEF \< 50%); 2. High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular conduction blocks (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block); 3. Angina pectoris requiring anti-anginal drug therapy; 4. Clinically significant valvular heart disease; 5. ECG showing a transmural myocardial infarction; 6. Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg); 7. Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated; 8. Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation.