Faslodex Registry: Fulvestrant in Current Clinical Practice
|ClinicalTrials.gov Identifier: NCT00735215|
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : December 23, 2009
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..
|Condition or disease|
|Metastatic Breast Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Faslodex Registry: a Belgian Observational Study to Evaluate the Use of Fulvestrant in Current Clinical Practice|
|Study Start Date :||October 2008|
|Actual Study Completion Date :||December 2009|
- 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 ]
- Document treatment during observation period and number of fulvestrant injections [ Time Frame: Visit 1, Visit 2 ]
- Document reasons for fulvestrant treatment discontinuation [ Time Frame: Visit 2 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735215
|Study Director:||Neven P Prof||KUL|