Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).
2 other identifiers
interventional
179
6 countries
31
Brief Summary
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jun 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 28, 2004
CompletedFirst Posted
Study publicly available on registry
September 29, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJune 12, 2008
June 1, 2008
September 28, 2004
June 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-proliferative effect after 4 weeks of treatment.
Secondary Outcomes (1)
Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.
Study Arms (2)
1
EXPERIMENTAL250 mg fulvestrant
2
EXPERIMENTAL500 mg fulvestrant
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women defined as women who have stopped having menstrual periods
- Written informed consent to participate in the trial
- Biopsy confirmation of invasive breast cancer
- Evidence of hormone sensitivity
- Willingness to undergo biopsies
You may not qualify if:
- Any previous treatment for breast cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
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
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Hershey, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
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Laredo, Texas, United States
Research Site
Innsbruck, Austria
Research Site
Salzburg, Austria
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Vienna, Austria
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Barretos, Brazil
Research Site
Florianópolis, Brazil
Research Site
Goiamia, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Berlin, Germany
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Hanover, Germany
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Magdeburg, Germany
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München, Germany
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Rostock, Germany
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Bangalore, India
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Hyderabaad, India
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New Delhi, India
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Pune, India
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Trivandrum, India
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Birmingham, United Kingdom
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Bournemouth, United Kingdom
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Dundee, United Kingdom
Research Site
Edinburgh, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Faslodex Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 28, 2004
First Posted
September 29, 2004
Study Start
June 1, 2004
Study Completion
July 1, 2007
Last Updated
June 12, 2008
Record last verified: 2008-06