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NCT00660803 Clinical Trial

Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:
Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00660803
Other study ID # NIS-OBR-FAS-2007/1
Secondary ID
Status Completed
Phase N/A
First received April 15, 2008
Last updated January 20, 2010
Start date May 2008
Est. completion date April 2009

Study information
Verified date January 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of HealthBrazil: National Health Surveillance Agency
Study type Observational

Clinical Trial Summary

Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Positive HR or ER by immunohistochemistry

- Postmenopausal status at the time of treatment with fulvestrant

- Failure of at least one previous endocrine therapy before treatment with fulvestrant.

Exclusion Criteria:

- Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Fulvestrant

Locations
Country Name City State
Brazil Research Site Porto Alegre RS
Brazil Research Site Recife PE
Brazil Research Site Rio de Janeiro RJ
Brazil Research Site Sao Paulo SP

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca Dendrix - Scientific Information Architecture

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to tumour progression No
Primary Objective response No
Secondary Duration of treatment with fulvestrant No
Secondary Time and duration of response No
Secondary Overall survival
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