Status:
UNKNOWN
Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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. The hypothesis of this study...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 11 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04452370
Start Date
September 23 2020
End Date
July 11 2023
Last Update
July 21 2021
Active Locations (1)
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1
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, China, 100021