Oral Etoposide Combined With Anlotinib in Advanced 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.

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

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute & Hospital. Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oral Etoposide+Anlotinib
anlotinib 12mg qd, d1-14,21days/cycle oral etoposide 75mg qd,d1-10,21days/cycle
anlotinib 12mg qd, d1-14,21days/cycle oral etoposide 75mg qd,d1-10,21days/cycle
Other Names:
  • there is no other intervention name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate(ORR)
Time Frame: 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)
up to 1 year after the last patient enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS)
Time Frame: 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
up to 1 year after the last patient enrolled
Incidence and Severity of adverse events
Time Frame: approximately 1.5 years
hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria
approximately 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2020

Primary Completion (Anticipated)

July 11, 2022

Study Completion (Anticipated)

July 11, 2023

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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