Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04452370
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
33.5
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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 oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: oral etoposide + anlotinib
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
Actual Study Start Date :
Sep 23, 2020
Anticipated Primary Completion Date :
Jul 11, 2022
Anticipated Study Completion Date :
Jul 11, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: oral Etoposide+Anlotinib

anlotinib 12mg qd, d1-14,21days/cycle oral etoposide 75mg qd,d1-10,21days/cycle

Drug: oral etoposide + anlotinib
anlotinib 12mg qd, d1-14,21days/cycle oral etoposide 75mg qd,d1-10,21days/cycle
Other Names:
  • there is no other intervention name
  • Outcome Measures

    Primary Outcome Measures

    1. objective response rate(ORR) [up to 1 year after the last patient enrolled]

      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

    1. Progression free survival(PFS) [up to 1 year after the last patient enrolled]

      PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause

    2. Incidence and Severity of adverse events [approximately 1.5 years]

      hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Cancer Institute & Hospital. Chinese Academy of Medical SciencesBeijingChina100021

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peng Yuan, Principal Investigator, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT04452370
    Other Study ID Numbers:
    • NCC2225
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2021