Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer (BC)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00880711
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-13
• Study First Posted: 2009-04-14
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-29
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
• Ability to read and write and complete questionnaires
• Provision of written informed consent
• Patients who already received a prescription for fulvestrant

Exclusion Criteria

• A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease	Baseline, after 3, 6, 9 month

Secondary Outcome Measures

Name	Time	Method
Tolerability	After 3, 6, 9 month (as per usual clinical practice)
Quality of Life	Baseline, after 3, 6, 9 month (as per usual clinical practice)
Performance status (Karnofsky Index)	Baseline, after 3, 6, 9 month (as per usual clinical practice)

Trial Locations

Locations (1)

Research Site; 🇦🇹 Wr. Neustadt, Austria