NCT01561443已完成不适用
LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive 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
- 153
- 试验地点
- 1
- 主要终点
- Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer
研究概览
简要总结
This is the first study focused on features/stereotypes of the first and second-line treatment patterns in Russia, comparison of different treatments, and determination of effective hormone treatment patterns in real-life practice with evaluation of pharmacoeconomic aspects. Study LINE is designed for collection of data on clinical effectiveness of second-line hormone treatment and quality of life in patients with breast cancer(BC).
详细描述
LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 women with hormone receptor-positive breast cancer:
- •Recurrence after the adjuvant hormone therapy;
- •Or initially inoperable locally advanced or metastatic breast cancer progressed after the first line hormone therapy;
- •Ability to read and write and complete questionnaires Provision of written informed consent
- •Patients who have already been prescribed therapy with the above-mentioned lines and who can continue on the prescribed therapy in the investigator's opinion according to his/her regular clinical practice and cure
排除标准
- •As per study design, to ensure high validity of data and to obtain accurate information on real-life practice,
- •Patients currently participating in other clinical studies will not be included in this study
结局指标
主要结局
Collection of data of routine regimens of hormone therapy in postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer
时间窗: 2 years
次要结局
- Quality of life (QoL): the extent of reduction in QoL deficit from 1 visit(2 years)
- Historical data analysis: treatment patterns effectiveness, duration of the adjuvant or first-line hormone treatment(2 years)
- Co-morbidities and relevant historical data(2 years)
- The information on spontaneous office visit to oncologist or hospitalization including reasons, diagnosis, days of hospitalization, procedures and concomitant medication changes will be collected.(2 years)
- Performance status (ECOG)(2 years)
- The extent of reduction anxiety inventory(2 years)
- Response duration(2 years)
- Effectiveness: Tumor regression; number of patients with complete response (CR), partial response (PR) or stable disease(2 years)
研究者
研究点 (1)
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