- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932526
Recruitment Status Not yet recruiting
First Posted April 30, 2019
Last update posted April 30, 2019
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.
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.
|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.
|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.
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.-->
- Female patients with recurrent or metastatic TNBC, as confirmed by histological or
- 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
- 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
- Allergic to target drugs or allergic to related drugs applied in the trial
- Pregnant or lactating women
Contact: Tao Sun, M.D. 86-024-31986682 firstname.lastname@example.org
Liaoning Tumor Hospital & Institute
Principal Investigator: Tao Sun Liaoning Tumor Hospital & Institute