Breast cancer
Conditions
Interventions
Treatment group:TCbH+Pyrotinib
control group:TCbH
Sponsors
Sir Run Run Shaw Hospital Zhejiang University School of Medical
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women aged from 18 to 70 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; 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=1.5×10^9/L; PLT=80×10^9/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×ULN; ALT and AST<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;Biomarker; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;DFS;ORR;DDFS; | — |
Countries
China
Contacts
Public ContactWenhe Zhao
Sir Run Run Shaw Hospital Zhejiang University School of Medical
Outcome results
None listed