A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
NCT ID: NCT00313170
Last Updated: 2020-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2006-05-30
2019-03-13
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 250 mg)
Fulvestrant
intramuscular injection 250 mg \& 500 mg
2
Fulvestrant 250 mg (+ 250 mg loading regimen)
Fulvestrant
intramuscular injection 250 mg \& 500 mg
3
Fulvestrant 500 mg (intramuscular injection 500 mg)
Fulvestrant
intramuscular injection 250 mg \& 500 mg
Interventions
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Fulvestrant
intramuscular injection 250 mg \& 500 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requiring hormonal treatment.
* Postmenopausal women (woman who has stopped having menstrual periods)
Exclusion Criteria
* Treatment with more than one previous regimen of endocrine therapy for advanced BC.
* An existing condition that prevents compliance.
45 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Brussels, , Belgium
Research Site
Leuven, , Belgium
Research Site
Roeselare, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Sault Ste. Marie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Cheb, , Czechia
Research Site
Jičín, , Czechia
Research Site
Prague, , Czechia
Research Site
Bordeaux, , France
Research Site
Brivé, , France
Research Site
Clermont-Ferrand, , France
Research Site
Poitiers, , France
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Győr, , Hungary
Research Site
Szeged, , Hungary
Research Site
Tatabánya, , Hungary
Research Site
Bydgoszcz, , Poland
Research Site
Gdansk, , Poland
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Olsztyn, , Poland
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.
Related Links
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Other Identifiers
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FINDER II
Identifier Type: -
Identifier Source: secondary_id
D6997C00006
Identifier Type: -
Identifier Source: org_study_id
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