Description:
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
Title
- Brief Title: Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
- Official Title: Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
NCC2225
- NCT ID:
NCT04452370
Conditions
- Triple Negative Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
oral etoposide + anlotinib | there is no other intervention name | oral Etoposide+Anlotinib |
Purpose
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
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 is to discover if the oral Etoposide plus Anlotinib can shrink
or slow the growth of pretreated advanced TNBC.
Trial Arms
Name | Type | Description | Interventions |
---|
oral Etoposide+Anlotinib | Experimental | anlotinib 12mg qd, d1-14,21days/cycle oral etoposide 75mg qd,d1-10,21days/cycle | - oral etoposide + anlotinib
|
Eligibility 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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | objective response rate(ORR) |
Time Frame: | up to 1 year after the last patient enrolled |
Safety Issue: | |
Description: | The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR) |
Secondary Outcome Measures
Measure: | Progression free survival(PFS) |
Time Frame: | up to 1 year after the last patient enrolled |
Safety Issue: | |
Description: | PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause |
Measure: | Incidence and Severity of adverse events |
Time Frame: | approximately 1.5 years |
Safety Issue: | |
Description: | hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Chinese Academy of Medical Sciences |
Last Updated
July 21, 2021