Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Faslodex Registry: Fulvestrant in Current Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00735215
First received: August 12, 2008
Last updated: December 21, 2009
Last verified: December 2009

August 12, 2008
December 21, 2009
October 2008
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00735215 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Faslodex Registry: Fulvestrant in Current Clinical Practice
Faslodex Registry: a Belgian Observational Study to Evaluate the Use of 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..

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Woman with post-menopausal breast cancer.

Metastatic Breast Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2009
Not Provided

Inclusion Criteria:

  • Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer

Exclusion Criteria:

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00735215
NIS-OBE-FAS-2008/1
No
Anna Chioti, MD, Therapeutic Area Leader Oncology, AstraZeneca Belgium
AstraZeneca
Not Provided
Study Director: Neven P Prof KUL
AstraZeneca
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP