Faslodex Registry: Fulvestrant in Current Clinical Practice

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00735215

Enrollment

200

Registered

2008-08-14

Start date

2008-10-31

Completion date

2009-12-31

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer,, fulvestrant,, postmenopausal,, women, locally advanced,, hormone receptor-positive.

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..

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Document treatment during observation period and number of fulvestrant injections	Visit 1, Visit 2
Document reasons for fulvestrant treatment discontinuation	Visit 2

Countries

Belgium

Outcome results