Know Cancer

forgot password

Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study

18 Years
80 Years
Not Enrolling
Malignant Neoplasm of Breast Stage IV

Thank you

Trial Information

Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study

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

Inclusion Criteria:

- 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

- 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.

Exclusion Criteria:

- Having received treatment with unapproved or experimental drugs during the study

- Presenting another concomitant cancer other than stage I cervical cancer or cutaneous
tumours without lymph node or distant involvement.

Type of Study:


Study Design:

Time Perspective: Retrospective

Outcome Measure:

Progression Free Survival

Outcome Description:

Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival

Outcome Time Frame:

22 months

Safety Issue:


Principal Investigator

Isabel Blancas, MD

Investigator Role:

Principal Investigator


Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

January 2012

Completion Date:

August 2012

Related Keywords:

  • Malignant Neoplasm of Breast Stage IV
  • Fulvestrant
  • Faslodex
  • Breast Neoplasms
  • Neoplasms