Trial Information
Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
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
Outcome Time Frame:
Baseline, after 3, 6, 9 month
Safety Issue:
No
Principal Investigator
Guenther Steger, Univ Prof. Dr.
Investigator Role:
Study Chair
Investigator Affiliation:
Medical University of Vienna
Authority:
Austria: Ethikkommission
Study ID:
NIS-OAT-FAS-2009/1
NCT ID:
NCT00880711
Start Date:
April 2009
Completion Date:
December 2010
Related Keywords:
- Breast Cancer
- Fiona
- Faslodex
- Advanced Breast Cancer
- Real life data
- Collect real life data in clinical practice across Austria
- Breast Neoplasms