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Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in 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. Identifier: NCT03932526
Recruitment Status : Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Information provided by (Responsible Party):
Sun Tao, Liaoning Tumor Hospital & Institute

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.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer Drug: Vinorelbine + placebo Drug: Vinorelbine + Apatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 12, 2022
Estimated Study Completion Date : June 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Vinorelbine + placebo group
92 enrolled patients will be assigned to receive oral vinorelbine plus placebo until disease progression or other criteria for administration termination.
Drug: Vinorelbine + placebo
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.
Other Name: AiTan+ placebo

Experimental: Vinorelbine + Apatinib group
92 enrolled patients will be assigned to receive oral patatinib mesylate in combination with vinorelbine until disease progression or other criteria for administration termination.
Drug: Vinorelbine + Apatinib
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.
Other Name: Navelbine+AiTan

Primary Outcome Measures :
  1. Progress-Free Survival(PFS) [ Time Frame: Day 1 of treatment until disease progression or death from any cause, assessed up to 24 months ]
    PFS refers to the length of time from random enrollment to any recorded tumor progression or death from any cause.

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 24 months ]
    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.

  2. Disease control rate (DCR) [ Time Frame: Up to 24 months ]
    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.

  3. Overall remission rate (ORR) [ Time Frame: Up to 24 months ]
    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.

  4. Adverse events at levels 3 and 4 [ Time Frame: every 6 weeks (two cycles) and 4 weeks after treatment discontinuation ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03932526

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Contact: Tao Sun, M.D. 86-024-31986682

Sponsors and Collaborators
Liaoning Tumor Hospital & Institute
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Principal Investigator: Tao Sun Liaoning Tumor Hospital & Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sun Tao, Department director, Liaoning Tumor Hospital & Institute Identifier: NCT03932526    
Other Study ID Numbers: STao-003
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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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
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators