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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.
Sponsor: AstraZeneca
Summary
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
Official title: A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Key Details
Gender
FEMALE
Age Range
45 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
736
Start Date
2005-02-13
Completion Date
2026-12-31
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Fulvestrant
intramuscular injection
Locations (106)
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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