An Epidemiological Prospective Cohort Study to Describe Treatment Patterns of Fulvestrant And ExemeSTane in Postmenopausal Patients With Advanced HR+ Breast Cancer Under Real-life Conditions in GERmany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
研究概览
简要总结
For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For all patients, to collect and explore real-life data on the epidemiology and management of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with Faslodex 500 mg or exemestane.
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
- •Signed written informed consent
- •Female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years Postmenopause ist defined as
- •Age ≥ 60 years and natural menopause with menses > 1year ago or
- •FSH and E2 levels in the postmenopausal range or
- •Patients who had bilateral ovariectomy (NCCN V.I. 2009)
- •Histologically confirmed ER+ locally advanced or metastatic breast cancer
- •Not eligible for curative therapy
- •Prior treatment with tamoxifen
- •Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
- •Patient is able to read and understand German
排除标准
- •Known hypersensitivity to Faslodex or Exemestane or any compounds of the drugs
- •Prior treatment with Faslodex 500 mg or Faslodex 250 mg*
- •for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
- •Prior treatment with Exemestane for patients who receive treatment with Exemestane within this observational study
- •Acutely life threatening disease
- •Treatment with Faslodex 250 mg/month (previously approved dose)
- •Prior palliative chemotherapy
结局指标
主要结局
Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
时间窗: Period from inclusion up to 9 months (average time period )
Disease management data
时间窗: Period from inclusion up to 9 months (average time period )
The analysis will be adjusted for the main prognostic factors, such as visceral metastases, age, receptor status etc
次要结局
- Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.(Every 3 months)
- Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).(Every 3 months)
- Real-life pharmacoeconomic data and use of health care resources.(Every 3 months)