Breast cancer
Conditions
Interventions
treatment group:EC+Pyrotinib?TH+Pyrotinib
control group:EC?TH
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged from18 to 75 years; 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; 3. Histologically confirmed invasive breast cancer(early stage or locally advanced):Primary tumour greater than 2 cm diameter; 4. HER2 positive (HER2+++ by IHC or FISH+); 5. Known hormone receptor status; 6. The main viscera function of patients must be normal, and should meet the following requirements: 1) blood routine examination meeting the standards:ANC=1.5×109/L; PLT=80×109/L; Hb=90g/L(no blood transfusion and blood components support within 14 days, not using G-CSF and other hematopoietic stimulating factor correction); 2) blood biochemical examination meeting the following standards: TBIL<1.5×ULNALTAST<2.5×ULN, hepatic metastasis ALT, AST < 5×ULNBUN and Cr=1×ULN, endogenous creatinine clearance =50 ml/min; 7. For women who before menopausal or have not undergone surgical sterilization: consent to abstinence or use of effective contraceptive methods during treatment and at least 7 months after the last dose in the study treatment; 8. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. metastatic disease (Stage IV) breast cancer; 2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix; 3. Also receive anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 4. Surgery that was not associated with breast cancer within 4 weeks prior to enrollment, or the patient has not recovered from such surgery; 5. Severe heart disease or discomfort, including but not limited to the following diseases: history of diagnosis of heart failure or systolic dysfunction (LVEF 100 bpm, Significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular block (ie Mobitz II second degree atrioventricular block or third degree atrioventricular block); need anti-angina medication Angina pectoris; clinically significant valvular heart disease; ECG shows transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 6. The following several factors ,such as unable to swallow, chronic diarrhea and intestinal obstruction; 7. Was allergic to the study drug or any of its excipients, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 8. Female patients during pregnancylactation or were positive after baseline pregnancy test, women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study medication; 9. Have concomitant or other disorder diseases that may interfere with planned treatment, or any other condition that the investigator believes is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;ORR;Biomarker;cardiotoxicity; | — |
Countries
China
Contacts
Public ContactOuchen Wang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed