Faslodex Specific Clinical Experience Investigation

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01501266
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.

Detailed Description

MC MD

Study Timeline

• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Study Start: 2012-02
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

• Patients treated with Faslodex for the first time due to postmenopausal breast cancer

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events.	1 Year
Incidence of adverse drug reactions.	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment	1 year
Progression-free survival	1 year

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan