Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
NCT ID: NCT00093002
Last Updated: 2008-06-12
Study Results
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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COMPLETED
PHASE2
179 participants
INTERVENTIONAL
2004-06-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
250 mg fulvestrant
Fulvestrant
250 mg \& 500 mg intramuscular injection
2
500 mg fulvestrant
Fulvestrant
250 mg \& 500 mg intramuscular injection
Interventions
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Fulvestrant
250 mg \& 500 mg intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent to participate in the trial
* Biopsy confirmation of invasive breast cancer
* Evidence of hormone sensitivity
* Willingness to undergo biopsies
Exclusion Criteria
* Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
* Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
* The presence of more than one primary tumor
* History of hypersensitivity to castor oil
* History of known bleeding disorders
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Faslodex Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Little Rock, Arkansas, United States
Research Site
Boston, Massachusetts, United States
Research Site
Winchester, Massachusetts, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Laredo, Texas, United States
Research Site
Innsbruck, , Austria
Research Site
Salzburg, , Austria
Research Site
Vienna, , Austria
Research Site
Barretos, , Brazil
Research Site
Florianópolis, , Brazil
Research Site
Goiamia, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Santo André, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Berlin, , Germany
Research Site
Hanover, , Germany
Research Site
Magdeburg, , Germany
Research Site
München, , Germany
Research Site
Rostock, , Germany
Research Site
Bangalore, , India
Research Site
Hyderabaad, , India
Research Site
New Delhi, , India
Research Site
Pune, , India
Research Site
Trivandrum, , India
Research Site
Birmingham, , United Kingdom
Research Site
Bournemouth, , United Kingdom
Research Site
Dundee, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Countries
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Related Links
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Medline Plus - Information on Breast Cancer
Breastcancer.org
Other Identifiers
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D6997C00003
Identifier Type: -
Identifier Source: secondary_id
9238IL/0065
Identifier Type: -
Identifier Source: org_study_id