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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 184
- 主要终点
- Progress-Free Survival(PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vinorelbine + placebo group
92 enrolled patients will be assigned to receive oral vinorelbine plus placebo until disease progression or other criteria for administration termination.
干预措施: Vinorelbine + placebo (Drug)
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.
干预措施: Vinorelbine + Apatinib (Drug)
结局指标
主要结局
Progress-Free Survival(PFS)
时间窗: 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.
次要结局
- Adverse events at levels 3 and 4(every 6 weeks (two cycles) and 4 weeks after treatment discontinuation)
- Overall remission rate (ORR)(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- Disease control rate (DCR)(Up to 24 months)
研究者
Sun Tao
Department director
Liaoning Tumor Hospital & Institute