Clinical Trials /

Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer

NCT04452370

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
oral etoposide + anlotinibthere is no other intervention nameoral 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

NameTypeDescriptionInterventions
oral Etoposide+AnlotinibExperimentalanlotinib 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:Not yet recruiting
Lead Sponsor:Chinese Academy of Medical Sciences

Last Updated

June 29, 2020