Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer

• Status: Recruiting
• Trial end date: 2023-07-11
• Target enrollment: 0
• Participant gender: Female

Summary

The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.

It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer

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

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Etoposide

Criteria

Inclusion Criteria:

• Age between 18 and 75 year-old women; TNBC

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

• Pathologically or cytologically confirmed breast cancer;

• Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-3 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 ≥4 chemotherapies 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;

• Prior treatment with etoposide or antiangiogenic TKI (subjects with prior use of antiangiogenic macromolecules such as bevacizumab are allowed to be enrolled);

• The patients have uncontrollable mental illness；

• Serous cavity effusion (such as pleural effusion and ascites) with clinical symptoms requiring clinical intervention or stable time less than 4 weeks;

• 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;

• Active or uncontrolled infection requiring systematic treatment (except simple urinary tract infection or upper respiratory tract infection) during the 2 weeks or 2 weeks prior to enrollment;

• Previous or concurrent history of other malignant tumors.Except for the cured skin basal cell carcinoma and cervical carcinoma in situ;

• The patients do have good compliance to the therapy.