The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
NCT ID: NCT00065325
Last Updated: 2015-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
694 participants
INTERVENTIONAL
2003-08-31
2014-09-30
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
Exemestane
Exemestane
oral capsule
2
Fulvestrant
Fulvestrant
intramuscular injection
Interventions
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Fulvestrant
intramuscular injection
Exemestane
oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
* Postmenopausal women defined as a women who has stopped having menstrual periods
* Evidence of hormone sensitivity
* Written informed consent to participate in the trial
Exclusion Criteria
* Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
* Treatment with an investigational or non-approved drug within one month
* 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 or Exemestane (i.e. castor oil or Mannitol)
32 Years
91 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Faslodex Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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Arcadia, California, United States
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Fountain Valley, California, United States
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Laverne, California, United States
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Long Beach, California, United States
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Santa Rosa, California, United States
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Torrington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Pensacola, Florida, United States
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Athens, Georgia, United States
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Chicago, Illinois, United States
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Harvey, Illinois, United States
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Springfield, Illinois, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Kalamazoo, Michigan, United States
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Royal Oak, Michigan, United States
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Saint Joseph, Michigan, United States
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Hooksett, New Hampshire, United States
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Livingston, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Canton, Ohio, United States
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Hershey, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Spartenburg, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Richmond, Virginia, United States
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Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Brussels, Belgium, Belgium
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Leuven, Belgium, Belgium
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Ottignies, Belgium, Belgium
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Wilrijk, Belgium, Belgium
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Goiânia, Goiás, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Penticton, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Aalborg, , Denmark
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Herning, , Denmark
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Hillerød, , Denmark
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København Ø, , Denmark
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Roskilde, , Denmark
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Sønderborg, , Denmark
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Bordeaux, , France
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Lille, , France
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Montpellier, , France
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Vandœuvre-lès-Nancy, , France
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Augsburg, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Regensburg, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Haifa, , Israel
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Tel Aviv, , Israel
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Obninsk, Kaluga Oblast, Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Klerksdorp, North West, South Africa
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Bloemfontein, South Africa, South Africa
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Cape Town, South Africa, South Africa
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Johannesburg, South Africa, South Africa
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Port Elizabeth, South Africa, South Africa
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Pretoria, South Africa, South Africa
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Hospitalet Dellobregat(barcelo, Catalonia, Spain
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Terrassa(barcelona), Catalonia, Spain
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Madrid, Madrid, Spain
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Valencia, Valencia, Spain
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Halmstad, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Nottingham, , United Kingdom
Countries
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References
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Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24.
Related Links
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MEDLINEplus related topics: Breast Cancer
MEDLINEplus related topics: Cancer (General)
MEDLINEplus related topics: Cancer--Living with Cancer
Aromasin related topics: Your Treatment with Aromasin
Other Identifiers
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EFECT
Identifier Type: -
Identifier Source: secondary_id
D6997C00048
Identifier Type: -
Identifier Source: secondary_id
9238IL/0048
Identifier Type: -
Identifier Source: org_study_id
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