recurrent/metastatic triple-negative breast cancer
Conditions
Interventions
capecitabine 1000mg/m2, Bid, D1-14, Q3W
after 6 cycles of PD patients without apatinib 500mg/ days + capecitabine 500mg
Sponsors
The Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, females; 2. ECOG score=2; 3. Histological diagnosed breast cancer and IHC assay shows ER (-), PR (-), HER -2/neu (-); 4. pathology or clinical diagnosis of recurrence and distant metastasis, after at least one treatment of disease progress; 5. 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; 6. Expected lifetime acuity = 3 months; 7. 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); 8. 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); 9. 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; 10. 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 (not including endostar); 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; | — |
Countries
China
Contacts
Public ContactYongkui Lu
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed