NCT00737009已完成不适用
An Observational Study of Adherence to Adjuvant Anastrozole Therapy in Postmenopausal Patients With Early Breast Cancer Over One Year Follow-up.
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
- 259
- 试验地点
- 1
- 主要终点
- To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
研究概览
简要总结
The purpose of this study is to describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes) and estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up.
研究设计
- 研究类型
- Observational
- 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 woman with early breast cancer who are prescribed with anastrozole as adjuvant endocrine therapy under the routine clinical practice.
- •Histologically or cytologically proven to be HR+(ER or PR +)
- •No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
- •Provision of written informed consent
排除标准
- •Recurrence of breast cancer
- •Known hypersensitivity to anastrozole or to any of its excipients
- •Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize adherence with the trial protocol: Amenorrhea<12 months and a intact uterus; Previous inclusion in the present study; Participation in a other clinical study during the last 30 days·
- •Women who does not agreed to participate the program
结局指标
主要结局
To describe adherence to anastrozole treatment current practice: cases where anastrozole treatment was halted ( timescale and causes)
时间窗: every 3- 6 months (4 visit in one year)
次要结局
- Estimate the proportion of postmenopausal women with early breast cancer who continue anastrozole therapy after one year follow-up(every 3- 6 months (4 visit in one year))
- Identify predictors of non- adherence(every 3- 6 months (4 visit in one year))
- The proportion of DFS after 1 year follow-up(every 3- 6 months (4 visit in one year))
- Describe menopausal symptoms(every 3- 6 months (4 visit in one year))
研究者
研究点 (1)
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