Faslodex Registry: Fulvestrant in Current Clinical Practice
The sequential administration of endocrine therapies to patients with advanced breast cancer requires the availability of therapies with different modes of actions, so that tumours developing resistance to one agent are not cross resistant to another. Because of its mechanism of action, fulvestrant is distinct from other hormonal therapies, which therefore limits the possibility of cross-resistance with other therapies such as tamoxifen and the aromatase inhibitors (AIs)
- In this way, patients may benefit from an extended period of endocrine treatment, which has considerable tolerability and quality-of-life advantages over cytotoxic chemotherapy.
- In Belgium, fulvestrant is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. However, little information is currently available on how fulvestrant is actually being used by physicians in Belgium. The optimum sequence of endocrine treatment for advanced breast cancer has yet to be defined and may depend on certain patient or disease characteristics.
Fulvestrant has been granted reimbursement by the Belgian Health authorities (RIZIV/INAMI) with the recommendation to collect the real life data necessary to assess the patients' breast cancer treatment history that may influence the actual endocrine treatment sequence according to physicians current clinical practice..
Metastatic Breast Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Faslodex Registry: a Belgian Observational Study to Evaluate the Use of Fulvestrant in Current Clinical Practice|
- to collect real life data on the use of fulvestrant in clinical practice in Belgium. Previous therapies (hormonal and chemo) for breast cancer and for advanced breast cancer will be documented for each patient. [ Time Frame: Visit 1, Visit 2 ] [ Designated as safety issue: Yes ]
- Document treatment during observation period and number of fulvestrant injections [ Time Frame: Visit 1, Visit 2 ] [ Designated as safety issue: No ]
- Document reasons for fulvestrant treatment discontinuation [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2009|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735215
|Study Director:||Neven P Prof||KUL|