A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
NCT ID: NCT00305448
Last Updated: 2012-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2006-03-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Fulvestrant 250 mg intramuscular injection
Fulvestrant
250 intramuscular injection
2
Fulvestrant 250mg (Plus 250mg Loading Regimen)
Fulvestrant
250 intramuscular injection
3
Fulvestrant 500 mg
Fulvestrant
500 mg intramuscular injection
Interventions
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Fulvestrant
250 intramuscular injection
Fulvestrant
500 mg intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requiring hormonal treatment
* Postmenopausal women defined as a woman who has stopped having menstrual periods
Exclusion Criteria
* Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Japan Medical Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Asahi, Chiba, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Daito, Fukushima, Japan
Research Site
Kōriyama, Fukushima, Japan
Research Site
Ōta, Gunma, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Kure, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki, Hyōgo, Japan
Research Site
Matsubaracho, Kagoshima-ken, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Niigata, Niigata, Japan
Research Site
Ōita, Oita Prefecture, Japan
Research Site
Kurashiki, Okayama-ken, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Morohongō, Saitama, Japan
Research Site
Shinden, Saitama, Japan
Research Site
Shizuoka, Shizuoka, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Koto-ku, Tokyo, Japan
Research Site
Kawasaki, , Japan
Countries
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Other Identifiers
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FINDER I
Identifier Type: -
Identifier Source: secondary_id
D6997C00004
Identifier Type: -
Identifier Source: org_study_id
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