Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 11, 2023
  • participants needed
    100
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 2 August 2021
measurable disease
metastasis
triple negative breast cancer
taxane

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

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

Details
Condition Breast Cancer, Triple Negative Breast Cancer
Treatment oral etoposide + anlotinib
Clinical Study IdentifierNCT04452370
SponsorChinese Academy of Medical Sciences
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

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 >1cmother examination >2cm)
The patients have enough organ function. The laboratory test indexes must comply with the following requirements
Blood routine: neutrophil1.5G/L, platelet count 80G/L, hemoglobin 90g/L
Liver function: serum bilirubin 1.5 times the upper limit of normal value; ALT and AST2.5 times the upper limit of normal value; ALT and AST5 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/minCockcroft-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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