A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

Inclusion criteria

• Age: 18-70 years;
• Clinical T2-T4d, or T1c with axillary lymph node positivity;
• 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；
• Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
• No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
• Neutrophil count absolute value ≧2.0×109/L;
• Hemoglobin ≧ 100g/L;
• Platelet count ≧100×109/L;
• Total bilirubin \<1.5 ULN (upper limit of normal);
• Creatinine \< 1.5×ULN
• AST/ALT \< 1.5×ULN;
• Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
• Reproductive age women, negative serum pregnancy test within 14 days before randomization;
• ECOG score 0 or 1;
• Signature of informed consent.

Exclusion criteria

• Stage IV (metastatic) breast cancer;
• Bilateral breast cancer;
• Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
• Patients with a second primary malignancy, except for adequately treated skin cancer;
• Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
• Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:
• History of heart failure or systolic dysfunction (LVEF \< 50%);
• 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);
• Angina pectoris requiring anti-anginal drug therapy;
• Clinically significant valvular heart disease;
• ECG showing a transmural myocardial infarction;
• Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg);
• Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated;
• 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.