Faslodex Post Marketing Surveillance

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00860561
• Lead Sponsor: AstraZeneca

Brief Summary

This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Postmenopausal women
• Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
• Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)

Exclusion Criteria

• The patients who received Faslodex treatment before

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Faslodex is assessed by proper method among CT scan, MRI, Ultrasound, etc. The RECIST criteria for target and non-target lesions will be used to evaluate efficacy.	5 years
Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting.	5 years

Trial Locations

Locations (1)

Research Site; 🇰🇷 Suwon-si, Korea, Republic of