To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study

To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer.

Inclusion Criteria:18-70 years old, Female;Subjects with histopathologically confirmed invasive breast cancer;HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);No distant metastasis;Lymph node positive or negative, primary tumour≥2cm;Lymph node negative，primary tumour≤2cm and any of the following factors; 1) Histological grade 3; 2) ER negative (<10%) and PR negative (<20%); 3) Age<35 years old; 4) Pathological hint: vascular invasion or intravascular cancer thrombus;Surgery was completed and chemotherapy was started within 8 weeks after surgery;Before and after chemotherapy LVEF≥55%;ECOG performance status of 0-1;Signed the informed consent.Exclusion Criteria:Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma);For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal;Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg;NYHA cardiac insufficiency grading ≥ Ⅲ grade;Severe, uncontrollable systemic disease;Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment;Subjects who participated in other clinical trials at the same time;Subjects determined by the investigator to be inappropriate to participate in this study.