NCT04247035Unknown不适用
Non-Interventional, Multi-center Registry of Recording of Treatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
Hellenic Society of Medical Oncology1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluation of the outcome per treatment line
研究概览
简要总结
• To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
详细描述
- To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece
- To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
- To record adverse events per line of therapy
- To recording of the causes of treatment discontinuation per line of therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women with histological confirmed ER/PR positive, HER2-negative MBC
- •Age >18 years old
- •Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC
- •Adequate hematologic, renal and hepatic function
- •Signed informed consent (ICF)
排除标准
- •Active malignancy other than MBC
- •Active infection
结局指标
主要结局
Evaluation of the outcome per treatment line
时间窗: 5 years
To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
次要结局
未报告次要终点
研究者
研究点 (1)
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