A Study Comparing the Efficacy of TCbHP and ECHP-THP in the Neoadjuvant Treatment of HER2-positive Breast Cancer

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, HER2, pathological complete remission Read More

Inclusion Criteria:

1. 18 years ≤ age ≤ 65 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1；
2. Clinical T2-T4d, or T1c with axillary LN+；
3. HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization [fish] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital；
4. Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization
5. Organ and bone marrow function test within one month before chemotherapy showed no chemotherapy contraindication： Absolute value of neutrophil count ≥ 2.0×10^9 / L Hemoglobin ≥ 100g / L Platelet count ≥ 100×10^9 / L Total bilirubin < 1.5 ULN (upper limit of normal value) Creatinine < 1.5 × ULN AST/ALT < 1.5×ULN
6. Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%)；
7. For women of childbearing age, serum pregnancy test was negative 14 days ；
8. Signed the informed consent form prior to patient entry；

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer;
2. supraclavicular lymph node metastasis；
3. For this disease, chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. have been received;
4. The patient has a second primary malignancy other than adequately treated skin cancer;
5. The patient has undergone major surgical procedures not related to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
6. The patient has severe heart disease or discomfort, including but not limited to the following:Diagnosed history of heart failure or systolic dysfunction (LVEF < 50%)；High-risk uncontrolled arrhythmias；Angina pectoris requiring antianginal medication；Clinically significant heart valve disease；ECG showing transmural myocardial infarction；Poorly controlled high blood pressure；
7. Because the patient has other serious and uncontrollable medical diseases, the investigator believes that chemotherapy is contraindicated;
8. Known history of allergy to the drug components of this regimen; history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;