Breast Cancer
Conditions
Interventions
Experimental group:Capecitabine plus pyrrolotinib plus trastuzumab
control group:Capecitabine plus pyrrolotinib
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients with metastatic or newly treated stage 4 breast cancer aged >= 18 years and <= 75 years; 2. Patients with ECoG grade 0-1; 3. Patients with breast cancer meeting the following criteria: invasive breast cancer confirmed by histology, her-23 + detected by immunohistochemistry or HER2 positive detected by fish; 4. Patients who had been treated with paclitaxel combined with trastuzumab or paclitazumab (adjuvant, neoadjuvant or advanced first-line) failed; 5. Patients with evaluable lesions; 6. Patients with good functional level of main organs (routine blood test, biochemical test, heart, liver, lung and kidney function); 7. Women of childbearing age were negative in pregnancy test and were willing to use appropriate contraceptive methods during the test and within 8 weeks after the last administration of the test drug; 8. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 2. Patients with severe cardiovascular diseases in the past: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms for male and >= 470 MS for female); cardiac insufficiency of grade III-IV according to NYHA standard, or left ventricular ejection fraction (LVEF) 1.0g) should be carefully enrolled; 4. Patients with abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN) and bleeding tendency; 5. Those who have a history of psychotropic drug abuse and can not give up or have mental disorders; 6. Patients with known allergic history to the drug components of the protocol, history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 7. Patients with severe concomitant diseases or other comorbid diseases that may interfere with the planned treatment, or any other situation that the researcher considers that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate (ORR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactZhengkui Sun
Jiangxi Cancer Hospital
Outcome results
None listed