NCT00523315已完成不适用
A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early 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
- 862
- 试验地点
- 2
研究概览
简要总结
To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice
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
- •Provision of written informed consent
- •Patients with early breast cancer who are scheduled to receive first-line adjuvant endocrine therapy with aromatase inhibitor under the routine clinical practice
- •Histologically or cytologically proven to be HR+(ER or PR +)
- •Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by the local guideline):
- •Age >= 50 years
- •Age < 50 years with amenorrhoea > 12 months and an intact uterus
- •FSH levels within postmenopausal range (over 30-40 IU/ml), or
- •Having undergone a bilateral oophorectomy.
- •No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators
排除标准
- •Recurrence of breast cancer
- •Known hypersensitivity to aromatase inhibitor or to any of the excipients
- •Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol
- •Previous inclusion in the present study
- •Participation in a clinical study during the last 30 days
研究者
研究点 (2)
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