NCT01144572已完成不适用
A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
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
- 494
- 试验地点
- 1
- 主要终点
- The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
研究概览
简要总结
The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer.
- •Undergoing upfront AIs adjuvant treatment within 7 days.
排除标准
- •Patients who disagree to participate this study
- •Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements.
- •The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.
结局指标
主要结局
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.
时间窗: 24 months
次要结局
- The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months(6-18 months)
- The change of the emotional well-being (EWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months(6-18 months)
- The change of the social well-being (SWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months.(6-18 months)
研究者
研究点 (1)
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