Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
NCT ID: NCT00038103
Last Updated: 2010-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2002-01-31
2008-03-31
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
NONE
Study Groups
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1.
Exemestane
Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
2.
Celecoxib + Exemestane
Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
Interventions
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Exemestane
Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
Celecoxib + Exemestane
Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following \> 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.
* at least one measurable lesion
Exclusion Criteria
* Previous hormonotherapy for advanced disease other than Tamoxifen.
* Myocardial infarction within previous 6 mo
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Antwerp, , Belgium
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Namur, , Belgium
Pfizer Investigational Site
Wilrijk, , Belgium
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Sydney, Nova Scotia, Canada
Pfizer Investigational Site
Bogotá, Bogota . DC, Colombia
Pfizer Investigational Site
Cali, , Colombia
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Mumbai, Maharashtra, India
Pfizer Investigational Site
Pune, Maharashtra, India
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Lima, Lima Province, Peru
Pfizer Investigational Site
Lima, Lima Province, Peru
Pfizer Investigational Site
Manila, , Philippines
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191139
Identifier Type: -
Identifier Source: secondary_id
NQ8-01-02-013
Identifier Type: -
Identifier Source: org_study_id
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