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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vinorelbine + placebo group | Active Comparator | 92 enrolled patients will be assigned to receive oral vinorelbine plus placebo until disease progression or other criteria for administration termination. |
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| Vinorelbine + Apatinib group | Experimental | 92 enrolled patients will be assigned to receive oral patatinib mesylate in combination with vinorelbine until disease progression or other criteria for administration termination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine + placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-Free Survival(PFS) | PFS refers to the length of time from random enrollment to any recorded tumor progression or death from any cause. | Day 1 of treatment until disease progression or death from any cause, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Sun, M.D. | Contact | 86-024-31986682 | jianong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Sun | Liaoning Cancer Hospital & Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32448335 | Derived | 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. |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| Vinorelbine + Apatinib | Drug | 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. |
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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. |
| Up to 24 months |
| 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. | Up to 24 months |
| 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. | every 6 weeks (two cycles) and 4 weeks after treatment discontinuation |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |