Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGPegylated liposomal doxorubicin
Drug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle.
DRUGEpirubicin
Drug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DRUGCyclophosphamid
Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DRUGTrastuzumab
Drug: Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DRUGPertuzumab
Drug: Pertuzumab (840 mg loading dose at first day only, then 420 mg) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DRUGDocetaxel
Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Shanghai Pudong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18-70 years old, Female; 2. Subjects with histopathologically confirmed invasive breast cancer; 3. HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity); 4. No distant metastasis; 5. Lymph node positive or negative, primary tumour≥2cm; 6. 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; 7. Surgery was completed and chemotherapy was started within 8 weeks after surgery; 8. Before and after chemotherapy LVEF≥55%; 9. ECOG performance status of 0-1; 10. Signed the informed consent.
Exclusion criteria
1. Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients; 2. 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); 3. For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment); 4. 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; 5. Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease; 6. Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg; 7. NYHA cardiac insufficiency grading ≥ Ⅲ grade; 8. Severe, uncontrollable systemic disease; 9. Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment; 10. Subjects who participated in other clinical trials at the same time; 11. Subjects determined by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year incidence of cardiotoxicity | 1-year |
Countries
China
Contacts
Primary ContactYongping Li
Outcome results
None listed