A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
研究概览
简要总结
This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
详细描述
A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician.
- •The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection.
- •Provision of subject informed consent.
排除标准
- •If participating in any controlled clinical trial, the subject cannot take part in this study.
- •Hypersensitivity to the active substance, or to any of the other excipients.
- •Pregnancy and lactation, or severe hepatic impairment.
结局指标
主要结局
To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
时间窗: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
次要结局
- Objective response rate (ORR)(Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.)
- Severity of Adverse Events(Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.)
- Frequency of Adverse Events(Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.)