breast cancer
Conditions
Interventions
Two groups:Apatinib Mesylate Tablets versus Docetaxel combined with Docetaxel
Sponsors
Breast center of Jiangxi Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 year-old women; 2. Have at least one extracranial measurable site of disease according to RECIST 1.1 criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of disease progression since the radiation; 3. Have failed for at least one chemotherapy regimen, but at most five regimens(Barring adjuvant and neo-adjuvant setting). Metastatic Triple-Negative Breast Cancer Patients; 4. In previous programmes, there must be at least one taxol chemotherapeutic drug and the occurrence of disease progr ession or the use of taxus chemotherapy drugs for more than 4 cycles; 5. ECOG score 0-1; 6. expected survival time = 3months; 7. Major organ function is normal, that meet the following criteria; (1) Blood test standards subject to (No blood transfusion and blood products within 14 days, without the use of G-CSF and other hematopoietic stimulating factors t o correct): Hb=100g/L; ANC=1.5×10^9/L; PLT=100×10^9/L; (2) Biochemical examination must meet the following criteria: TBIL<1.5×ULN; ALT/AST<2.5×ULN Liver metastases<5×ULN; BUN and Cr=1×ULN or endogenous creatinine clearance rate)=50ml/min (Cockcroft-Gault formula); 8. the women of childbearing age must do the pregnancy test (serum or urine) within 7 days when they are included i n the trial, And the result was negative, and during the trial and at the time of giving experimental drugs after 8 weeks using the appropriate methods of contraception; 9. the participants volunteered to join this study should sign the informed consent forms, have better compliance, work in with the follow-up.
Exclusion criteria
Exclusion criteria: 1. people with high blood pressure and antihypertensive drug treatment could not be reduced to within the normal range (systolic >140 mmHg, diastolic pressure >90 mmHg); 2. with grade II myocardial ischemia, poor controlled arrhythmias or myocardial infarction (including QTc interval male =450 Ms, female =470 Ms); according to NYHA standard III-IV class heart insufficiency or heart ultrasound: LVE F (left ventricular ejection fraction) 1.0g); Patients with weak positive proteinuria (±) should be carefully enrolled in the group; 4. dysfunction of blood coagulation (INR>1.5 or prothrombin time ( PT )> ULN+4 Seconds); 5. patients with a history of psychotropic drug abuse and in capable of abstinence or mental disorder; 6. Patients who have previously used other small molecule TKI targeting drug therapy; 7. According to the researchers' judgment, there are other serious harm to patients who are safe or affect patients who have completed the study with the disease; 8. Patients with metastases of the central nervous system; 9. patients with pregnancy or lactation; 10. Anyone researcher considered not suitable for participating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactZhengkui Sun
Breast center of Jiangxi Tumor Hospital
Outcome results
None listed