Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 7
- 主要终点
- Progression Free Survival
研究概览
简要总结
This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500.
详细描述
Based on the results of the CONFIRM Study, a centralised change in the dosage of Faslodex® to 500 mg/month, with an additional pre-loading dose of 500 mg fourteen days after treatment smart was authorised in Europe; the dose is indicated for the treatment of post-menopausal women with ABC, hormone receptor positive and whose disease had progressed after anti-estrogen therapy.
Several sites worldwide participated in this study, but given the importance of the results obtained and their impact, we believe it is important to have local data available in Spain that would enable us to determine how this new 500 mg dose of Faslodex® behaves in the treatment and to assess treatment response within standard clinical practice and the current indications of this drug.
Therefore, we designed this retrospective, observational study in which we will measure response in term of PFS using data collected from the Clinical History.
Likewise, other variables will be studied: OS, CBR, duration of clinical benefit, tolerability and safety. Patient subgroups, like those who over-express her-2, according to levels of ki-67 and the presence or not of visceral metastases will also be studied.
This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and duration of clinical benefit (DCB, in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500, had occurred at some point between 1 January 2010 and 31 October 2011 (hereinafter, the study period).
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent from patients when possible.
- •In the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data.
- •Post-menopausal women.
- •Diagnosed with locally advanced or Metastatic Breast Cancer with histological/cytological confirmation.
- •Documented estrogen receptor positive status for the primary tumour.
- •Patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose during the study period.
排除标准
- •Having received treatment with unapproved or experimental drugs during the study period.
- •Presenting another concomitant cancer other than stage I cervical cancer or cutaneous tumours without lymph node or distant involvement.
结局指标
主要结局
Progression Free Survival
时间窗: 22 months
Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Clinical Benefit Rate(22 months)
- Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2(22 months)
- Overall Survival(22 months)
- Duration of Clinical Benefit(22 months)
- Number of Participants With Adverse Events(22 months)
- Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases(22 months)
- Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy(22 months)
- Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67(22 months)
研究者
Isabel Blancas
Medical Doctor
Hospital Clinico Universitario San Cecilio