Anlotinib in Metastatic HER2 Negative Breast Cancer

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: Female

Summary

The hypothesis of this study is to discover if the anlotinib can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peng Yuan

Criteria

Inclusion Criteria:

• Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);

• ECOG score: 0-1, expected survival time ≥ 3months;

• Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-2 standard chemotherapies after recurrence and metastasis;

• According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm，other examination >2cm);

• 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)

• 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；

• Can swallow oral drugs;

• 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:

• The patients in pregnancy or lactation growth period and did not take effective contraception;

• 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;

• The patients with a variety of factors that affect the oral administration and absorption of drugs;

• The patients with rapid progression of viscera invasion(liver lesion >1/2 viscera area or liver dysfunction);

• The patients have uncontrollable mental illness.

• The patients who had serious adverse effect to oral etoposide or were allergic to etoposide.

• The patients who have only bone metastasis without other measurable lesion;

• The patients experience severe cardiovascular diseases;

• The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.

• Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin <90g/L);

• Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value);

• Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);

• The patients have uncontrollable brain metastasis;

• The patients do not have good compliance to the therapy.