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

Inclusion Criteria:

• To take part in the trial, patients must be aged > 18 years old and supply a signedinformed consent form. Patients must also have breast cancer meeting the following criteria:
• Histologically confirmed invasive breast carcinoma
• Clinical stage II-IIIC at presentation. HER2-positive breast cancer scored as 3+ byimmunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 geneamplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situhybridization (ISH). Known hormone receptor status (ER and PR). Eastern Cooperative Oncology Group (ECOG)Performance Status 0 or 1. Completed all necessary baseline laboratory and radiologicexaminations prior to randomization. Baseline left ventricular ejection fraction (LVEF)≥55% measured by echocardiography (ECHO). Women who are not postmenopausal (≥12 months of amenorrhea) or surgically sterile (absenceof ovaries and/or the uterus) must agree to remain abstinent or to use one highly effectiveform of non-hormonal contraception or two effective forms of non-hormonal contraceptionduring the treatment period and for at least 6 months after the last dose of studytreatment. Clinical diagnosis of Alzheimer's Disease. Must be able to swallow tablets. All patientsmust be able to comply with the study protocol, according to the investigator's judgment.

Exclusion Criteria:

• Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancertherapy or radiotherapy for any malignancy. A history of other malignancies, exceptfor 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 beforerandomization 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-riskuncontrolled arrhythmia, such as atrial tachycardia with a heart rate >100 bpm at rest,significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-gradeatrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AVblock). Angina pectoris requiring anti-angina medication. Clinically significant valvular heartdisease. Evidence of transmural infarction on ECG Poorly controlled hypertension (systolicblood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) Other concurrentserious diseases that may interfere with planned treatment, including severe pulmonaryconditions/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'ssyndrome, total bilirubin > 2 × ULN Aspartate aminotransferase (AST) and/or alanineaminotransferase (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 <1500cells/uL Platelet count <100,000 cells/uL Sensitivity to any of the study medications, anyof the ingredients or excipients of these medications, or benzyl alcohol Pregnant orlactating: a negative serum pregnancy test is required for all women who are notpostmenopausal (≥ 12 months of amenorrhea). Insulin dependent diabetes. Thyroid disease.