Breast Cancer
Conditions
Keywords
Fiona, Faslodex, Advanced Breast Cancer, Real life data, Collect real life data in clinical practice across Austria
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Austria
Outcome results
None listed