Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)

Exclusion Criteria

• •Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancer therapy or radiotherapy for any malignancy. A history of other malignancies, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma.
• •Concurrent anti-cancer treatment in another clinical trial, including hormone therapy, bisphosphonate therapy, or immunotherapy.
• •Received a major non-breast cancer-related surgical procedure within the 4 weeks before randomization or from which the patient has not fully recovered.
• •A serious cardiac illness or medical condition, including but not limited to the following:
• •Documented history heart failure or systolic dysfunction (LVEF \< 50%). High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate \>100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block).
• •Angina pectoris requiring anti-angina medication. Clinically significant valvular heart disease. Evidence of transmural infarction on ECG Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.
• •Any of the following abnormal laboratory tests immediately prior to randomization:
• •Total bilirubin \> 1.5 × upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin \> 2 × ULN Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.25 × ULN Alkaline phosphatase \> 2.5 × ULN Serum creatinine \> 1.5 × ULN Total white blood cell (WBC) count \< 2500 cells/uL Absolute neutrophil count \<1500 cells/uL Platelet count \<100,000 cells/uL Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol Pregnant or lactating: a negative serum pregnancy test is required for all women who are not postmenopausal (≥ 12 months of amenorrhea).
• •Insulin dependent diabetes. Thyroid disease.