Study of Apatinib Combined With Oral Vinorelbine in Metastatic HER2 Negative Breast Cancer

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES · May 10, 2016

Keywords

ClinConnect Summary

Apatinib is an orally administered second-generation blocker of the phosphorylation of the tyrosine residues within the intracellular domain of VEGF receptor 2 (VEGFR2). A prospective, open label, phase II multicenter trial of apatinib in heavily pretreated patients with metastatic triple-negative breast cancer demonstrated that the daily dose of apatinib 500 mg/day is active in pretreated metastatic TNBC with encouraging rates of disease stabilization and PFS.

Vinorelbine is a highly active drug in the treatment of MBC, both as a single agent or in combination regimens, and is well tolera...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 year-old women; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);
• • 2. ECOG score: 0-1, expected survival time ≥ 3months;
• • 3. Pathologically or cytologically confirmed breast cancer;
• • 4. Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-2 standard chemotherapies after recurrence and metastasis;
• • 5. According to RECIST 1.1, exist at least ≥1 measurable lesion(CT \>1cm，other examination \>2cm) ;
• 6. The patients have enough organ function. The laboratory test indexes must comply with the following requirements:
• • Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance \>50ml/min（Cockcroft-Gault formula)
• • 7. Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration；
• • 8. Can swallow oral drugs;
• • 9. The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
• Exclusion Criteria:
• • 1. The patients in pregnancy or lactation growth period and did not take effective contraception;
• • 2. The patients who received ≥3 chemotherapies（Do not include endocrine therapy）after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
• • 3. The patients with a variety of factors that affect the oral administration and absorption of drugs；
• • 4. The patients previously received anti-VEFG of anti-VEGFR therapies；
• • 5. The patients with rapid progression of viscera invasion(liver lesion \>1/2 viscera area or liver dysfunction);
• • 6. The patients have uncontrollable mental illness.
• • 7. The patients who had serious adverse effect to oral vinorelbine or were allergic to vinorelbine.
• • 8. The patients who have only bone metastasis without other measurable lesion;
• • 9. The patients experience severe cardiovascular diseases;
• • 10. The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.
• • 11. Abnormal bone marrow functions(neutrophil\<1.5G/L, platelet count \<75G/L, hemoglobin \<90g/L)；
• • 12. Abnormal renal function(serum creatinine \> 1.5 times the upper limit of normal value)；
• • 13. Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);
• • 14. The patients have uncontrollable brain metastasis;
• • 15. The patients do not have good compliance to the therapy.