NCT02023359已完成不适用
Observational Study of Everolimus in Combination With Exemestane in Postmenopausal Patients With Hormone Receptor-positive, HER 2-negative Advanced Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Adverse Events
研究概览
简要总结
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved Summary of Product Characteristics (SmPC).
- •Patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events.
- •The decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study.
- •The patient must provide signed Informed Consent before any data can be captured.
排除标准
- •No formal exclusion criteria
研究组 & 干预措施
Treatment
Everolimus and exemestane
干预措施: Everolimus and exemestane (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 2.5 years
次要结局
- Overall response rate(Up to 2.5 years)
- Clinical benefit rate(Up to 2.5 years)
- Overall survival(Up to 2.5 years)
- Time on treatment with everolimus(Up to 2.5 years)
- Reason for stopping treatment with everolimus(Up to 2.5 years)
- Progression free survival(Up to 2.5 years)
研究者
研究点 (3)
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