Faslodex Registry: Fulvestrant in Current Clinical Practice

NCT ID: NCT00735215

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

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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..

Detailed Description

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Conditions

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Metastatic Breast Cancer

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Belgium

Principal Investigators

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Neven P Prof

Role: STUDY_DIRECTOR

KUL

Locations

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Research Site

Antwerp, , Belgium

Site Status

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Bruges, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Namur, , Belgium

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Ostend, , Belgium

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Roeselare, , Belgium

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Turnhout, , Belgium

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Wilrijk, , Belgium

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Countries

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Belgium

Other Identifiers

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NIS-OBE-FAS-2008/1

Identifier Type: -

Identifier Source: org_study_id