Malignant Neoplasm of Breast Stage IV Clinical Trial
Official title:
Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study
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.
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).
Thus, we will obtain the PFS, OS and CBR data, as well as information on safety and
tolerability.
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Time Perspective: Retrospective