NCT03086785Unknown2 期
Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年11月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 to 70 years old (female)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less
- •Patients with at least one measurable lesions of the advanced breast cancer， measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO);
- •Major organ function has to meet the following certeria:
- •For results of blood routine test (without blood transfusion within 14 days)
- •ANC≥1.5×109/L;
- •PLT≥75×109/L;
- •For results of blood biochemical test：
- •TBIL<1.5ULN；
- •ALTand AST<2.5ULN, but5<ULN if the transferanse elevation is due to liver metastases；
- •Serum creatinine ≤1.25ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula); 6.Participants were willing to join in this study, and written informed consent.
排除标准
- •The patients with the failure of capecitabine treatment；
- •The patients with chest wall invasion, or chest wall large canker has a tendency to transfer；
- •Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease, unable to control arrhythmia (including QTc lengthened women > 470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction (LVEF) < 50%；
- •A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)；
- •Has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period （+ +）and above of defecate occult blood, vasculitis, etc；
- •Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound；
- •Allergic to apatinib and supplementary material；
- •Patients with active brain metastases;
- •Patients with pregnant or planning a pregnancy;
- •The researchers think inappropriate.
研究组 & 干预措施
apatinib
Experimental
apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
次要结局
- Disease control rate(tumor assessment every 6 weeks since the treatment began，up to 24 months)
- Side effects(evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0)
- Overall survival(the first day of treatment to death or last survival confirm date,up to 24 months)
- Objective response rate(tumor assessment every 6 weeks since the treatment began，up to 24 months)
研究者
研究点 (1)
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