Breast Cancer
Conditions
Interventions
Case series:Apatinib+Second-line chemotherapy
Sponsors
The first Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years old female; 2. ECOG(Eastern Cooperative Oncology Group) 0~2; 3. The Expected lifetime =12 weeks; 4. Histologically or cytologically confirmed diagnosis of locally recurrence or metastatic breast cancer 5. Progression or failure of first-line chemotherapy; 6. Recovery from the effects of prior therapy, including the following: 4 weeks from cytotoxic agents and radiotherapy; 7. Normal bone marrow function before the recruitment:WBC = 4×10^9/LANC =1.5 x 10^9/LPLT=100×10^9/LHb=90g/L; 8. Normal liver function before the recruitment ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis <5×ULN); ALP< 2.5×ULN,bilirubin< 1.5×ULN; 9. Normal renal function before the recruitmentserum creatinine=1.25 ×ULN or calculated creatinine clearance rate=50 mL/min; 10. The international normalized ratio (INR = 1.5) and prothrombin time (PPT or aPTT) =1.5 × ULN before the recruitment; 11. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 12. With written informed consent signed voluntarily by patients themselves.
Exclusion criteria
Exclusion criteria: 1. Allergy to the drugs in this protocol; 2. Pregnant and lactating women; 3. Any medical or other condition that in the opinion of the investigator would preclude the subjects participation in a clinical study; 4. Patients with peripheral neuropathy over grade ?NCI CTC-AE prior to study entry; 5. Patients with uncontrol hypertension in the use of two antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); 6. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g); 7. Patients with severe cardiovascular disease: Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval =470 ms).; According to NYHA standard , patients with grade III ~?cardiac insufficiencyleft ventricular ejection fraction (LVEF) under 50% confirmed by echocardiography; 8. The following several factors ,such as unable to swallow, chronic diarrhea and intestinal obstruction; 9. Cagulation abnormalities. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present; 10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or anticipation of need for major surgical procedure during the course of the study; 11. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month prior to study entry; 12. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 13. Pregnant or lactating women; patients with complete uterus(except for over 24 months of menopause) are reluctant or unable to take effective contraceptive measures; Conditions determined by investigators to possibly affect the clinical study or determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;Safty;OS; | — |
Countries
China
Contacts
Public ContactOuchen Wang
The first Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed