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.