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

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: HER2positivity 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 testswithin 1 month before chemotherapy:

6. Neutrophil count absolute value ≧2.0×109/L;

7. Hemoglobin ≧ 100g/L;

8. Platelet count ≧100×109/L;

9. Total bilirubin <1.5 ULN (upper limit of normal);

10. Creatinine < 1.5×ULN

11. AST/ALT < 1.5×ULN;

12. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);

13. Reproductive age women, negative serum pregnancy test within 14 days beforerandomization;

14. ECOG score 0 or 1;

15. 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, orradiotherapy for this disease;

4. Patients with a second primary malignancy, except for adequately treated skincancer;

5. Major non-breast cancer-related surgical procedures within the past 4 weeks beforeenrollment, 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:

7. History of heart failure or systolic dysfunction (LVEF < 50%);

8. High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heartrate > 100 bpm, significant ventricular arrhythmias (such as ventriculartachycardia) or higher-grade atrioventricular conduction blocks (i.e., MobitzII second-degree atrioventricular block or third-degree atrioventricularblock);

9. Angina pectoris requiring anti-anginal drug therapy;

10. Clinically significant valvular heart disease;

11. ECG showing a transmural myocardial infarction;

12. Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolicblood pressure > 100 mmHg);

13. Due to severe and uncontrolled other medical conditions, the investigator considerschemotherapy to be contraindicated;

14. Known history of allergy to any component of the study drugs; patients with ahistory of immune deficiency diseases, including HIV positivity, or patients withother acquired or congenital immune deficiency diseases, or a history of organtransplantation.