Faslodex Registry: Fulvestrant in Current Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00735215
First received: August 12, 2008
Last updated: December 21, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

Woman with post-menopausal breast cancer.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735215

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
Sponsors and Collaborators
AstraZeneca
Investigators
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 July 20, 2014