Breast Cancer
Conditions
Interventions
one:Docetaxel and Apatinib
Sponsors
Cancer Center of the Affiliated Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No156 Wujiadun, Wuhan, China.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patient aged 18-70 years; 2. There is at least one target lesion defined according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), and the target is not treated with radiation therapy (or other local treatment), unless the treatment is completed; 3. HER-2 negative metastatic breast cancer diagnosed by pathology recurrence: HER-2 negative immunohistochemical criteria for definite HER-2 (- / + / +), HER-2 (+ +), if need FISH/CISH confirmed that HER-2 amplification was negative; 4. At least 2 chemotherapy regimens have been accepted, and at least 5 chemotherapy regimens (not including neoadjuvant and adjuvant chemotherapy) have been accepted in the patients with HER-2 negative recurrence and metastatic breast cancer; 5. Must have had at least one taxane chemotherapy and had disease progression or taxane drug use more than 6 cycles in the previous scheme; 6. PS 0-1 ECOG points; 7. The expected survival time is March; 8. The main organ function is normal, that is, meet the following standards: 1) to comply with the standard of blood routine examination (blood transfusion and blood products, 14 days without the use of G-CSF and other hematopoietic stimulating factor correction): Hb = 100g/L; The ANC = 1.5 * 10^9/L; The PLT = 100*10^9/L; 2) biochemical tests in accordance with the following standards: TBIL < 1.5 * ULN; ALT, AST < 2.5 * ULN, there are liver metastasis < 5 * ULN; Creatinine clearance rate more than 50ml/min between BUN and Cr is less than 1 * ULN or endogenous (Cockcroft-Gault formula); 9. Women of childbearing age must carry out a pregnancy test (serum) within 7 days of entry, and the results are negative and are willing to use the appropriate method of contraception within 8 weeks of the trial period and the last administered drug; 10. The subjects volunteered to join the study should sign the informed consent with good compliance and the follow-up.
Exclusion criteria
Exclusion criteria: 1. With high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); 2. Who suffered from serious cardiovascular disease: the grade of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 MS); according to the standard of NYHA, III ~ IV heart function is not complete, or echocardiography showed that left ventricular ejection fraction (LVEF). 50%; 3. Urine protein positive patients (urine protein detection of 2+ or more, or 24 hours urine protein quantitative >1.0g), protein urine is weakly positive (+) patients should be cautious into the group; 4. Abnormal coagulation function (INR > 1.5, ULN > 1.5 APTT), with bleeding tendency; 5. With psychotropic drug abuse history and can't get rid of or mental disorder patients; 6. Previous use of other small molecule TKI targeted drug treatment of patients; 7. According to the investigator's judgment, there are other serious hazards to patients who are safe or affected by patients who complete the study of concomitant disease; 8. Patients with metastases to the central nervous system; 9. Pregnant or lactating women; 10. The researchers don't think that is suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactJing Cheng
Cancer Center of the Affiliated Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed