Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
NCT ID: NCT00099437
Last Updated: 2025-09-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
736 participants
INTERVENTIONAL
2005-02-13
2025-12-31
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 500 mg
Fulvestrant
intramuscular injection
2
Fulvestrant 250 mg
Fulvestrant
intramuscular injection
Interventions
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Fulvestrant
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
* Evidence of positive estrogen receptor hormone sensitivity
* Written informed consent to participate in the trial
Exclusion Criteria
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
* A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
* Treatment with more than one regimen of chemotherapy for advanced breast cancer
* Treatment with more than one regimen of hormonal treatment for advanced breast cancer
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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Faslodex Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Casa Grande, Arizona, United States
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Fountain Valley, California, United States
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New Britain, Connecticut, United States
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Crystal River, Florida, United States
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Fort Lauderdale, Florida, United States
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Urbana, Illinois, United States
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Rosedale, Maryland, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Voorhees Township, New Jersey, United States
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Greenville, North Carolina, United States
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Pasadena, Texas, United States
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West Bend, Wisconsin, United States
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Brasschaat, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Liège, , Belgium
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Turnhout, , Belgium
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Barretos, , Brazil
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Londrina, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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Antofagasta, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Bogotá, , Colombia
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Cali, , Colombia
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Brno, , Czechia
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České Budějovice, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tábor, , Czechia
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V Uvalu 84, , Czechia
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Nyíregyháza, , Hungary
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Székesfehérvár, , Hungary
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Szombathely, , Hungary
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Ansārinagar, , India
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Bhopal, , India
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Hyderabad, , India
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Jaipur, , India
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Kolkata, , India
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Manipal, , India
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Marg Jaipur, , India
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Mumbai, , India
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Pune, , India
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Trivandrum, , India
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Vellore, , India
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Aviano, , Italy
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Bergamo, , Italy
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Carpi, , Italy
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Genova, , Italy
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Prato, , Italy
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Reggio Emilia, , Italy
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Varese, , Italy
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Floriana, , Malta
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Mexico City, , Mexico
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México, , Mexico
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México, , Mexico
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Bialystok, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Ivanovo, , Russia
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Kazan, Tatarstan, , Russia
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Kazan, Tatarstan, , Russia
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Krasnodar, , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Obninsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Trnava, , Slovakia
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A Coruña, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Salamanca, , Spain
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Seville, , Spain
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Cherkasy, , Ukraine
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Dnipro, , Ukraine
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Donetsk, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Sumy, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Caracas, , Venezuela
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Caracas, , Venezuela
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Caracas, , Venezuela
Countries
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References
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Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
Related Links
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Other Identifiers
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2004-002371-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D6997C00002
Identifier Type: -
Identifier Source: org_study_id
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