Faslodex Registry: Fulvestrant in Current Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735215
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : December 23, 2009
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Brief Summary:

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
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
Study Start Date : October 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Document treatment during observation period and number of fulvestrant injections [ Time Frame: Visit 1, Visit 2 ]
  2. Document reasons for fulvestrant treatment discontinuation [ Time Frame: Visit 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Woman with post-menopausal breast cancer.

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00735215

Research Site
Antwerp, Belgium
Research Site
Brugge, Belgium
Research Site
Brussels, Belgium
Research Site
Gent, Belgium
Research Site
Kortrijk, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Research Site
Namur, Belgium
Research Site
Ostende, Belgium
Research Site
Roeselare, Belgium
Research Site
Turnhout, Belgium
Research Site
Wilrijk, Belgium
Sponsors and Collaborators
Study Director: Neven P Prof KUL

Responsible Party: Anna Chioti, MD, Therapeutic Area Leader Oncology, AstraZeneca Belgium Identifier: NCT00735215     History of Changes
Other Study ID Numbers: NIS-OBE-FAS-2008/1
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by AstraZeneca:
Breast cancer,
locally advanced,
hormone receptor-positive.

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs