NCT00880711已完成不适用
Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease
研究概览
简要总结
The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
- •Ability to read and write and complete questionnaires
- •Provision of written informed consent
- •Patients who already received a prescription for fulvestrant
排除标准
- •A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS
结局指标
主要结局
Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease
时间窗: Baseline, after 3, 6, 9 month
次要结局
- Tolerability(After 3, 6, 9 month (as per usual clinical practice))
- Quality of Life(Baseline, after 3, 6, 9 month (as per usual clinical practice))
- Performance status (Karnofsky Index)(Baseline, after 3, 6, 9 month (as per usual clinical practice))
研究者
研究点 (1)
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