Advanced breast cancer
Conditions
Interventions
Case series:Apatinib mesylate combined with Exemestane
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. Histologically confirmed breast cancer that was ER+ and/or PgR+, and negative for HER2 overexpression by immunohistochemistry or for HER2 gene amplification by fluorescent in situ hybridization; and pathology or clinical diagnosis of recurrence and distant metastasis; 3. Eligible patients were either postmenopausal or received ovarian suppression; 4. Refractory to any non-steroidal aromatase inhibitor; 5. ECOG score=2; 6. According to RECIST version 1.1 standard, the patient has at least one extracranial measurable lesions, and it can be measured that lesions has not received radiotherapy; 7. Expected lifetime acuity = 3 months; 8. Normal function of major organs should meet the following criteria: (1) the blood routine examination must be in accordance with standard: HB=90 g/L (14 days without blood transfusion); ANC=1.5×10^9/L; PLT=100×10^9/L; (2) the biochemical examination must be in accordance with the following criteria: TBIL=1.5×ULN; ALT and AST=2.5×ULN if has liver metastasis ALT and AST=5×ULN; Serum Cr=1×ULN or 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 negative; 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. Prior therapy with a steroidal AI(eg, exemestane) was not permitted unless it was administered in the adjuvant setting and =12 months had elapsed since last treatment; 2. Have high blood pressure and the antihypertensive drug treatment can't obtain good control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 3. Always suffer from severe cardiovascular disease: with level-II myocardial ischemia or myocardial infarction, with level-II arrhythmia (including QT interval=450 ms in men or =470 ms in female) or cardiac insufficiency; 4. Routine urine prompt urinary protein>++and 24 hours urinary protein quantitative>1.0 g; 5. Coagulant function abnormality (INR>1.5APTT>1.5 ULN); 6. Has a history of psychiatric drugs abuse and can't quit or has a history of mental disorders; 7. Always use a VEGFR, PDGFR and s - SRC kinase inhibitor drugs therapy; 8. According to the researcher's judgment, there are other serious diseases which endanger the safety of patients or influence the completion of this research; 9. Patients with uncontrolled brain/meningeal metastasis; 10. Pregnant or lactation women; 11. The researchers think that the patient doesn't fit into.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;CBR;OS; | — |
Countries
China
Contacts
Public ContactYongkui Lu
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed