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 (easy laugh)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Shanghai Pudong HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
pegylated liposomal doxorubicin;cyclophosphamide;trastuzumab;pertuzumab ;docetaxel
Epirubicin;cyclophosphamide f;docetaxel;trastuzumab;pertuzumab
Pegylated liposomal doxorubicin 35 mg/m2, i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1 +Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1 ; q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+ Pertuzumab 420 mg, i.v. d1+Trastuzumab 6 mg/kg, i.v. d1; q3w, for 4 cycles. After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab.
Epirubicin 90 mg/m2 , i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1; q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1; q3w, for 4 cycles. After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab.