Faslodex Registry: Fulvestrant in Current Clinical Practice

NCT00735215 | Completed

• 1 other identifier: NIS-OBE-FAS-2008/1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 12

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..

Conditions

Metastatic Breast Cancer

Keywords

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

Outcome Measures

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.

  Visit 1, Visit 2

Secondary Outcomes (2)

• Document treatment during observation period and number of fulvestrant injections

  Visit 1, Visit 2

• Document reasons for fulvestrant treatment discontinuation

  Visit 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Woman with post-menopausal breast cancer.

You may qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Antwerp, Belgium

Location

Research Site

Bruges, Belgium

Location

Research Site

Brussels, Belgium

Location

Research Site

Ghent, Belgium

Location

Research Site

Kortrijk, Belgium

Location

Research Site

Leuven, Belgium

Location

Research Site

Liège, Belgium

Location

Research Site

Namur, Belgium

Location

Research Site

Ostend, Belgium

Location

Research Site

Roeselare, Belgium

Location

Research Site

Turnhout, Belgium

Location

Research Site

Wilrijk, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Neven P Prof

  KUL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2008
• Study Completion: December 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

BE (12)