Clinical trial NCT00735215: Faslodex Registry: Fulvestrant in Current Clinical Practice
Official title: Faslodex Registry: a Belgian Observational Study to Evaluate the Use of Fulvestrant in Current Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer,
fulvestrant,
postmenopausal,
women
locally advanced,
hormone receptor-positive.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman with post-menopausal breast cancer.

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..


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: 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.
timeFrame: Visit 1, Visit 2
Secondary outcomes:
measure: Document treatment during observation period and number of fulvestrant injections
timeFrame: Visit 1, Visit 2
measure: Document reasons for fulvestrant treatment discontinuation
timeFrame: Visit 2
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Ostende
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
Study officials:
affiliation: KUL
name: Neven P Prof
role: STUDY_DIRECTOR
References: