Faslodex Registry: Fulvestrant in Current Clinical Practice

Metastatic Breast Cancer Clinical Trial

Official title:

Faslodex Registry: a Belgian Observational Study to Evaluate the Use of Fulvestrant in Current Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735215
• Other study ID #: NIS-OBE-FAS-2008/1
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: December 21, 2009
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Locations

Country	Name	City	State
Belgium	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Visit 1, Visit 2	Yes
Secondary	Document treatment during observation period and number of fulvestrant injections		Visit 1, Visit 2	No
Secondary	Document reasons for fulvestrant treatment discontinuation		Visit 2	No