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Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452370
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences

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 disease Intervention/treatment Phase
Triple Negative Breast Cancer 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 11, 2020
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/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 Name: there is no other intervention name




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Incidence and Severity of adverse events [ Time Frame: approximately 1.5 years ]
    hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452370


Contacts
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Contact: Peng Yuan 01087787245 yuanpeng01@hotmail.com

Locations
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China
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Peng Yuan Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Peng Yuan, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04452370    
Other Study ID Numbers: NCC2225
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action