Overview

Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Isabel Blancas
Treatments:
Estradiol
Fulvestrant
Criteria
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 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.

Exclusion Criteria:

- 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.