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CompletedNCT00735215Updated Dec 23, 2009

Faslodex Registry: Fulvestrant in Current Clinical Practice

An observational study in Metastatic Breast Cancer, sponsored by AstraZeneca. Completed at 12 sites in Belgium. Open to female participants. Per ClinicalTrials.gov, last updated 2009-12-23.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Sex
Female
01

Study 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..

02

Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • Breast cancer,
  • fulvestrant,
  • postmenopausal,
  • women
  • locally advanced,
  • hormone receptor-positive.
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 200 is close to the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Woman with post-menopausal breast cancer.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
06

What researchers measure

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

07

Study locations

12 sites
  • Research Site
    Antwerp, Belgium
  • Research Site
    Bruges, Belgium
  • Research Site
    Brussels, Belgium
  • Research Site
    Ghent, Belgium
  • Research Site
    Kortrijk, Belgium
  • Research Site
    Leuven, Belgium
  • Research Site
    Liège, Belgium
  • Research Site
    Namur, Belgium
  • Research Site
    Ostend, Belgium
  • Research Site
    Roeselare, Belgium
  • Research Site
    Turnhout, Belgium
  • Research Site
    Wilrijk, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00735215
Lead sponsor
AstraZeneca
First posted
Aug 14, 2008
Start date
Oct 2008
Completion
Dec 2009
Last update
Dec 23, 2009

Study contacts

Neven P Prof
study director · KUL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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