Abstract | BACKGROUND: METHODS/ANALYSIS: This study is a triple-blind, randomized, placebo-controlled, parallel-group clinical trial. We plan to include 238 female patients with locally recurrent or metastatic TNBC, admitted to the Liaoning Cancer Hospital & Institute, Northeast China. All enrolled patients will be randomized to oral vinorelbine alone (40 mg, thrice a week (Mondays, Wednesdays, and Fridays) in each 3-week cycle), or in combination with oral apatinib mesylate (500 mg, once daily in each 3-week cycle). Radiographic assessment will be performed every 6 weeks for 36 weeks and every 9 weeks thereafter. The primary outcome is progression-free survival and secondary outcomes include overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4, as defined by the National Cancer Institute Common Toxicity Criteria Version 4.0. Outcome measures will be evaluated at baseline (< 2 weeks before starting treatment), every 6 weeks during treatment, and at 4 weeks and every 3 months after treatment discontinuation. DISCUSSION: Based on the data from this trial, we hope to identify a treatment plan that is suitable for female patients with TNBC, who have been treated with anthracyclines and taxanes, in Northeast China. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03932526. Registered on 30 April 2019.
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Authors | Shuo Wu, Liang Zhang, Huan Li, Junnan Xu, Cui Jiang, Tao Sun |
Journal | Trials
(Trials)
Vol. 21
Issue 1
Pg. 420
(May 24 2020)
ISSN: 1745-6215 [Electronic] England |
PMID | 32448335
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
- Protein Kinase Inhibitors
- Pyridines
- apatinib
- Vinorelbine
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Topics |
- Administration, Oral
- China
- Clinical Trials, Phase II as Topic
- Disease-Free Survival
- Drug Therapy, Combination
- Humans
- Protein Kinase Inhibitors
(therapeutic use)
- Pyridines
(administration & dosage, adverse effects)
- Randomized Controlled Trials as Topic
- Time Factors
- Triple Negative Breast Neoplasms
(drug therapy, mortality, pathology)
- Vinorelbine
(administration & dosage, adverse effects)
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