advanced breast cancer
Conditions
Interventions
none:Apatinib 500mg/day
Sponsors
The First Hospital of Lanzhou Uiversity
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years,females; 2. ECOG performance status of 0 to 1; 3. Pathological examination diagnosed advanced (relapse or metastatic) breast cancer; 4. had at least one failure of chemotherapy regimens in treating (The definition of treatment failure: side effects cannot be tolerated, in the process of the treatment the disease progression or Disease relapses after treatment); If progress during neo-adjuvant therapyadjuvant therapy during or after the completion of six months or less recurrence it is assumed that neo-adjuvant/adjuvant therapy is a frontline systemic chemotherapy for advanced disease. HER2 positive patients allowed by bead an auxiliary or first-line treatment history; 5. Four weeks prior to the start of the study, patient was not received chemotherapy (the nitroso urea class or mitomycin for six weeks), radiation therapy, molecular targeted therapy, and surgery, and patient has recovered from a treatment of the acute toxicity reaction of before (if have surgery, the wound has healed completely); 6. According to RECIST version 1.1 standard (appendix), the patient has at least one extracranial measurable lesions,(Spiral CT scans =10 mm, CT scanning layer is not more than 5 mm thick), it can be measured that lesions has not received radiotherapy; 7. Expected lifetime acuity = 3 months; 8. Patients can have a history of brain/meningeal metastasis, but it must be before the start of the study after local treatment (surgery/radiotherapy), and clinically stable for at least eight weeks (it is allowed before or simultaneous use of glucocorticoid hormone drugs, but it must be a high dose, stable dose, and no adjustment after the start of the study, high dose is defined as 20 mg dexamethasone, other sugar cortical hormone drugs corresponding conversion); 9. Normal function of major organs should meet the following criteria: (1) the blood routine examination must be in accordance with standard: 1) HB=90 g/L (14 days without blood transfusion); 2) ANC=1.5×10^9/L; 3) PLT=80×10^9/L; (2) the biochemical examination must be in accordance with the following criteria: 1) TBIL=1.5×ULN (higher than the normal limit); 2) ALT and AST=2.5×ULNif has liver metastasis ALT and AST=5×ULN; 3) Serum Cr=1×ULN the endogenous creatinine clearance>50 ml/min (Cockcroft-Gault formula); 10. Women of childbearing age are willing to using appropriate methods of contraception during the test and 8 weeks after having the last experimental drug,and should have a pregnancy check before test if necessary,the result should be negtive. 11. Subjects were willing to join in this study, sign the informed consent, good adherence, and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactation women; 2. 4 weeks prior to the start of the study involved in other drug clinical trial; 3. Have high blood pressure and the single antihypertensive drug treatment can't obtain good control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-I myocardial ischemia or myocardial infarctionwith level-I arrhythmia (including QT interval=440 ms) or cardiac insufficiency; 4. The influence of oral drugs and absorption of a variety of factors (Such as unable to swallow, after resection of gastrointestinal tract, chronic diarrhea and intestinal obstruction); 5. Coagulant function abnormality, was treated with thrombolysis or anticoagulation, with a bleeding tendency or there are clear gastrointestinal bleeding concerns, (such as: there are local active ulcer lesions, defecate occult blood as positive); 6. A period of 6 months prior to the start of the study dynamic/enous thromboembolism event has occurred, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc; 7. Long term with chest and other parts of the wound or fracture; 8. Routine urine prompt urinary protein>++and 24 hours urinary protein quantitative>1.0 g; 9. There are serious or not controlled infection; 10. Has a history of psychiatric drugs abuse and can't quit or has a history of mental disorders; 11. The patients has a objective evidence of past and present medical history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, pulmonary function was seriously damaged; 12. Always use a VEGFR, PDGFR and s - SRC kinase inhibitor drugs therapy (allows the use of bevacizumab); 13. A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 14. Hepatitis b viral hepatitis (except the activity carriers) or hepatitis c patients; 15. The past five years has a history of other malignant tumors, but has been cured except skin basal cell carcinoma and cervical carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (progression-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate);OS(Overall survival);QoL (Quality of life); | — |
Countries
China
Contacts
Public ContactZhao da
The First Hospital of Lanzhou University
Outcome results
None listed