A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- Time to Progression
研究概览
简要总结
This is a retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on patients who have commenced treatment with fulvestrant after January 1st of 2007. All necessary information for the purposes of the present study will be collected with the use of a paper-Case Record Form.
详细描述
To date, there are no available data on the use of fulvestrant in the treatment of postmenopausal women with metastatic breast cancer in current clinical practice in Greece. In view of this significant lack of knowledge, we designed this retrospective study in order to evaluate the effectiveness of fulvestrant in real-life settings, by obtaining data regarding the use of fulvestrant in current clinical practice among treating physicians in Greece. This retrospective study aims to address the following questions:
- What is the clinical outcome of fulvestrant treatment in terms of TTP when used in metastatic breast cancer in a real life clinical setting?
- What is the positioning of fulvestrant in the hormone therapy sequencing in metastatic breast cancer in Greece?
- What are the other clinical outcomes (ORR, duration of response, CBR) of fulvestrant treatment in metastatic breast cancer in a real life clinical setting and what is the relation between clinical outcomes and fulvestrant's position in the treatment sequence?
- What is the usual duration of fulvestrant treatment in metastatic breast cancer in the real life clinical setting and which are the reasons for treatment discontinuation?
- Treatment failure with fulvestrant: what is the next step in sequencing according to patients' breast cancer treatment history?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 ER-positive and/or PgR-positive breast cancer who have failed at least one prior endocrine therapy, either as adjuvant treatment or for the treatment of advanced disease
- •Patients who have received treatment with fulvestrant for metastatic breast cancer and have completed/discontinued the treatment regardless of outcome/reason for discontinuation (except for treatment discontinuation for non-clinical reasons)
- •Patients who were at postmenopausal status at the time of treatment with fulvestrant
排除标准
- •Patients who are currently undergoing treatment with fulvestrant
- •Investigators/treating physicians with no available electronical or paper-based medical records
研究组 & 干预措施
Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Time to Progression
时间窗: 1 year
To evaluate the time to progression (TTP) from the initiation of fulvestrant treatment in postmenopausal women with endocrine-positive breast cancer who have failed at least one prior endocrine therapy, either as adjuvant treatment or for the treatment of advanced disease
次要结局
- Objective Response Rate(> 6 months)
- Tumor growth control(>6 months)