Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)
Condition: Malignant Neoplasm of Breast Stage IV
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fulvestrant
Intervention type(s): Drug
Intervention description(s): It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.
Other intervention name(s): Faslodex (registered)
Intervention MeSH terms: Fulvestrant
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Post-menopausal women with Advanced Breast Cancer (ABC) and estrogen receptor positive
        (ER+) who were treated with this medicinal product and at said dose after having progressed
        with a previous anti-estrogen therapy
      
Keywords: Fulvestrant; Faslodex