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
About this trial
This is an interventional treatment trial for Triple-negative Breast Cancer
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
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
NCT ID
NCT03932526
First Posted
April 15, 2019
Last Updated
April 26, 2019
Sponsor
Liaoning Tumor Hospital & Institute
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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