NCT01047358已完成不适用
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 206
- 试验地点
- 22
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
详细描述
All cases at the participating institutions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 breast cancer eligible for hormonal therapy.
排除标准
- •Pregnant breast-feeding premenopausal.
研究组 & 干预措施
ajuvant group
adjuvant setting after two to three years of tamoxifen
干预措施: Aromasin (Drug)
palliative group
palliative setting after progression of disease with anti-estrogen therapy
干预措施: Aromasin (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From the first dose of Aromasin through the end of the study for an average of 5.6 months
All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
次要结局
- Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)(At the end of the study, average of 5.6 months)
- Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)(At the end of the study, average of 5.6 months.)
- Time-to-Progression (Early Breast Cancer)(At the end of the study, average of 5.6 months)
研究者
研究点 (22)
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