Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Fulvestrant

• Registration Number: NCT00660803
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-17
• Study Start: 2008-05
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-20
• Last Update Posted: 2010-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Fulvestrant	Postmenopausal women with hormone-receptor positive, advanced breast cancer who have failed at least one previous endocrine therapy and who have been treated at any one of the participating centres with fulvestrant.

Primary Outcome Measures

Name	Time	Method
Time to tumour progression
Objective response

Secondary Outcome Measures

Name	Time	Method
Duration of treatment with fulvestrant
Time and duration of response
Overall survival

Trial Locations

Locations (1)

Research Site; 🇧🇷 Sao Paulo, SP, Brazil