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Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Triple-negative Breast Cancer

Primary Purpose

Triple-negative Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vinorelbine + placebo
Vinorelbine + Apatinib
Sponsored by
Liaoning Tumor Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-negative Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients with recurrent or metastatic TNBC, as confirmed by histological or cytological examination
  • Age 18-70 years old
  • According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, there is at least one measurable lesion.
  • The Eastern Cooperative Oncology Group (ECOG) scores 0-2
  • Expected survival ≥ 12 weeks
  • Negative for ER/PR
  • All patients will be tested for bone marrow capacity, liver and renal functions within 7 days prior to enrollment
  • Previous use of anthracyclines and/or taxanes
  • The medication history of vinorelbine
  • Female patients of childbearing age must take adequate contraception; otherwise the patients must be proven to be infertile
  • No history of serious heart, lung, liver, and kidney diseases
  • Provision of written informed consent

Exclusion Criteria:

  • Patients who receive chemotherapy, radiation therapy, targeted drugs, or hormone therapy within 3 weeks of administration
  • Patients using corticosteroids for untreated brain or subdural metastatic lesions, need to have stopped it, at least for 4 weeks or until there are no signs of brain metastasis and/or symptoms must have stabilized for at least 4 weeks, if local treatment has been completed. Enhanced computed tomography (CT) or magnetic resonance imaging (MRI) images during screening are compared with those performed at least 4 weeks earlier to determine radiological stability.
  • Patients with severe vascular diseases, including unstable angina, myocardial infarction, or severe arrhythmia in the past 6 months
  • History of HIV infection or active chronic hepatitis B or C
  • Patients with other serious infectious diseases
  • Patients positive for ER/PR/HER-2 positive
  • Patients with allogeneic organ transplants requiring immunosuppressive therapy
  • History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin
  • Other destabilizing factors that may interfere with patients or have an impact on the trial results
  • Allergic to target drugs or allergic to related drugs applied in the trial
  • Pregnant or lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Vinorelbine + placebo group

    Vinorelbine + Apatinib group

    Arm Description

    92 enrolled patients will be assigned to receive oral vinorelbine plus placebo until disease progression or other criteria for administration termination.

    92 enrolled patients will be assigned to receive oral patatinib mesylate in combination with vinorelbine until disease progression or other criteria for administration termination.

    Outcomes

    Primary Outcome Measures

    Progress-Free Survival(PFS)
    PFS refers to the length of time from random enrollment to any recorded tumor progression or death from any cause.

    Secondary Outcome Measures

    Overall survival (OS)
    OS indicates the length of time from enrollment to death from any cause.When no information on death is collected in the clinical database, the last date when the patient is still known to have survived is used as the cut-off point.
    Disease control rate (DCR)
    DCR indicates the percentage of patients with CR, partial remission, and disease stabilization; and maintenance over 4 weeks, accounts for all the subjects with evaluable efficacy.
    Overall remission rate (ORR)
    ORR is the proportion of patients who achieve a complete or partial response ((CR+PR)/total number of cases x 100%), as assessed by the RECIST v1.1.
    Adverse events at levels 3 and 4
    Patients with adverse events at levels 3 and 4 will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4.0.

    Full Information

    First Posted
    April 15, 2019
    Last Updated
    April 26, 2019
    Sponsor
    Liaoning Tumor Hospital & Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03932526
    Brief Title
    Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Triple-negative Breast Cancer
    Official Title
    Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Recurrent or Metastatic Triple-negative Breast Cancer: a Double-blinded Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 24, 2019 (Anticipated)
    Primary Completion Date
    December 12, 2022 (Anticipated)
    Study Completion Date
    June 26, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Liaoning Tumor Hospital & Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the therapeutic effect of vinorelbine used alone or combined with apatinib mesylate for recurrent or metastatic TNBC patients who have at least received one chemotherapy regimen, including anthracyclines and taxanes, providing clinical evidence for multi-line treatment options for advanced TNBC.
    Detailed Description
    The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; and its future therapeutic trend includes chemotherapy combined with molecular targeted therapy. Apatinib mesylate (Aitan), a novel small molecule anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase. Aitan also blocks the signaling of vascular endothelial growth factor binding to its receptor, thereby strongly inhibiting tumor angiogenesis and exerting anti-tumor effect.However, a randomized controlled clinical trial of apatinib combined with vinorelbine for TNBC has not been reported. The objective of this study is to compare the therapeutic effect of vinorelbine alone or combined with apatinib mesylate for recurrent or metastatic triple-negative breast cancer (TNBC) patients who have received at least two regimens containing anthracyclines and taxanes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Triple-negative Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    184 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vinorelbine + placebo group
    Arm Type
    Active Comparator
    Arm Description
    92 enrolled patients will be assigned to receive oral vinorelbine plus placebo until disease progression or other criteria for administration termination.
    Arm Title
    Vinorelbine + Apatinib group
    Arm Type
    Experimental
    Arm Description
    92 enrolled patients will be assigned to receive oral patatinib mesylate in combination with vinorelbine until disease progression or other criteria for administration termination.
    Intervention Type
    Drug
    Intervention Name(s)
    Vinorelbine + placebo
    Other Intervention Name(s)
    AiTan+ placebo
    Intervention Description
    Combined administration of vinorelbine and placebo. Based on oral administration of vinorelbine, the patients will be given oral placebo (starch as an ingredient). The placebo appearance, including shape, size, color and weight, taste, labeling and packing are the same with those of apatinib mesylate tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    Vinorelbine + Apatinib
    Other Intervention Name(s)
    Navelbine+AiTan
    Intervention Description
    Combined administration of vinorelbine and apatinib. Vinorelbine tartrate soft capsule (also named Navelbine; registration No. H20140657; Pierre Fabre Medicament, Boulogne, France) 40 mg once orally, taken in the morning (at least 1 hour before or at least 1 hour after meals), three times a week (Mondays, Wednesdays, and Fridays), for a continuous 21-day cycle. Apatinib mesylate tablets (also named Aitan, State Medical Permission No. H20140103; Jiangsu Hengrui Pharmaceutical Co., Ltd., China), 500 mg orally, taken once a day for a continuous 21-day cycle.
    Primary Outcome Measure Information:
    Title
    Progress-Free Survival(PFS)
    Description
    PFS refers to the length of time from random enrollment to any recorded tumor progression or death from any cause.
    Time Frame
    Day 1 of treatment until disease progression or death from any cause, assessed up to 24 months
    Secondary Outcome Measure Information:
    Title
    Overall survival (OS)
    Description
    OS indicates the length of time from enrollment to death from any cause.When no information on death is collected in the clinical database, the last date when the patient is still known to have survived is used as the cut-off point.
    Time Frame
    Up to 24 months
    Title
    Disease control rate (DCR)
    Description
    DCR indicates the percentage of patients with CR, partial remission, and disease stabilization; and maintenance over 4 weeks, accounts for all the subjects with evaluable efficacy.
    Time Frame
    Up to 24 months
    Title
    Overall remission rate (ORR)
    Description
    ORR is the proportion of patients who achieve a complete or partial response ((CR+PR)/total number of cases x 100%), as assessed by the RECIST v1.1.
    Time Frame
    Up to 24 months
    Title
    Adverse events at levels 3 and 4
    Description
    Patients with adverse events at levels 3 and 4 will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4.0.
    Time Frame
    every 6 weeks (two cycles) and 4 weeks after treatment discontinuation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients with recurrent or metastatic TNBC, as confirmed by histological or cytological examination Age 18-70 years old According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, there is at least one measurable lesion. The Eastern Cooperative Oncology Group (ECOG) scores 0-2 Expected survival ≥ 12 weeks Negative for ER/PR All patients will be tested for bone marrow capacity, liver and renal functions within 7 days prior to enrollment Previous use of anthracyclines and/or taxanes The medication history of vinorelbine Female patients of childbearing age must take adequate contraception; otherwise the patients must be proven to be infertile No history of serious heart, lung, liver, and kidney diseases Provision of written informed consent Exclusion Criteria: Patients who receive chemotherapy, radiation therapy, targeted drugs, or hormone therapy within 3 weeks of administration Patients using corticosteroids for untreated brain or subdural metastatic lesions, need to have stopped it, at least for 4 weeks or until there are no signs of brain metastasis and/or symptoms must have stabilized for at least 4 weeks, if local treatment has been completed. Enhanced computed tomography (CT) or magnetic resonance imaging (MRI) images during screening are compared with those performed at least 4 weeks earlier to determine radiological stability. Patients with severe vascular diseases, including unstable angina, myocardial infarction, or severe arrhythmia in the past 6 months History of HIV infection or active chronic hepatitis B or C Patients with other serious infectious diseases Patients positive for ER/PR/HER-2 positive Patients with allogeneic organ transplants requiring immunosuppressive therapy History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin Other destabilizing factors that may interfere with patients or have an impact on the trial results Allergic to target drugs or allergic to related drugs applied in the trial Pregnant or lactating women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tao Sun, M.D.
    Phone
    86-024-31986682
    Email
    jianong@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tao Sun
    Organizational Affiliation
    Liaoning Tumor Hospital & Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32448335
    Citation
    Wu S, Zhang L, Li H, Xu J, Jiang C, Sun T. Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial. Trials. 2020 May 24;21(1):420. doi: 10.1186/s13063-020-04342-x.
    Results Reference
    derived

    Learn more about this trial

    Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Triple-negative Breast Cancer

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