Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

AstraZeneca1 site in 1 country57 target enrollmentApril 2009

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: AstraZeneca
Enrollment: 57
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

December 2010

Last Updated

14 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline, after 3, 6, 9 month

Secondary Outcomes

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))