Status:
COMPLETED
Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)
Lead Sponsor:
Isabel Blancas
Conditions:
Malignant Neoplasm of Breast Stage IV
Eligibility:
FEMALE
18-80 years
Brief 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 s...
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 author...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT01509625
Start Date
January 1 2012
End Date
March 1 2014
Last Update
June 1 2016
Active Locations (7)
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1
Hospital San Cecilio
Granada, Granada, Spain
2
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
3
Hospital Torrecardenas Almería
Almería, Spain
4
Complejo Hospitalario de Jaén
Jaén, Spain