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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: After 3, 6, 9 month (as per usual clinical practice)
Quality of Life

Time frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Performance status (Karnofsky Index)

Time frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

Acronym: FIONA

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Apr 14, 2009
Registry last updated: Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed