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Completed

NCT Number: NCT00735215

Faslodex Registry: 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..

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Study completion
2009
First posted
Aug 14, 2008
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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