Sun Yat-sen University Cancer Center
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.
详细描述
This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •ECOG 0 or 1
- •Primary or metastatic tumor onfirmed as triple negative
- •Measurable disease per RECIST version 1.1
- •normal organ function, including bone marrow function, renal function, liver function, and cardiac function
- •Two or more prior chemotherapy
- •signed and dated an informed consent form
- •Life expectancy of at least 12 weeks
排除标准
- •Pregnant or breast feeding
- •ECOG score ≧2
- •Uncontrolled medical problems
- •Hepatic, renal, or bone marrow dysfunction as detailed above
- •Concurrent malignancy or history of other malignancy within the last five years except as noted above
- •Patients were unable or unwilling to comply with program requirements
研究组 & 干预措施
Icotinib
Icotinib 125 mg BID
干预措施: Icotinib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 36 months
the time from randomization to the date of disease progression or death from any causes
次要结局
未报告次要终点
研究者
Zhong-yu Yuan
Sun Yat-sen University Cancer Center
Sun Yat-sen University