Faslodex Registry: Fulvestrant in Current Clinical Practice
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Metastatic Breast Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Document treatment during observation period and number of fulvestrant injections [ Time Frame: Visit 1, Visit 2 ] [ Designated as safety issue: No ]
- Document reasons for fulvestrant treatment discontinuation [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2008 |
| Study Completion Date: | December 2009 |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Woman with post-menopausal breast cancer.
Inclusion Criteria:
- Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
Exclusion Criteria:
Contacts and Locations| 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, Belgium | |
| Study Director: | Neven P Prof | KUL |
More Information
No publications provided
| Responsible Party: | Anna Chioti, MD, Therapeutic Area Leader Oncology, AstraZeneca Belgium |
| ClinicalTrials.gov Identifier: | NCT00735215 History of Changes |
| Other Study ID Numbers: | NIS-OBE-FAS-2008/1 |
| Study First Received: | August 12, 2008 |
| Last Updated: | December 21, 2009 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by AstraZeneca:
|
Breast cancer, fulvestrant, postmenopausal, |
women locally advanced, hormone receptor-positive. |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 19, 2013