This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen...
Date First Received: May 29, 2002
Last Updated: June 9, 2008
Verified by: Pfizer, June 2008
Clinical Trial Phase: Phase 2 | Start Date: January 2002
Overall Status: Active, not recruiting
Estimated Enrollment: 111
Brief Summary
Official Title: “Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin) With Or Without Celecoxib (Celebrex) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen”
Condition Keyword(s):
Intervention(s):
This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- clinical benefit (defined as the frequency of tumor response and disease stabilization for at least 24 weeks) August 2003 Yes
Secondary:
- Other efficacy parameters than clinical benefit; tolerability; PD and PK June 2006 Yes
- Survival December 2012 No
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.
- 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:
- More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.
- Previous hormonotherapy for advanced disease other than Tamoxifen.
- Myocardial infarction within previous 6 mo
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pfizer
Pfizer Investigational Site
Dallas Texas 75204 United States
Pfizer Investigational Site
Leuven 3000 Belgium
Pfizer Investigational Site
WILRIJK 2610 Belgium
Pfizer Investigational Site
Antwerpen 2020 Belgium
Pfizer Investigational Site
Bruxelles 1000 Belgium
Pfizer Investigational Site
Namur 5000 Belgium
Pfizer Investigational Site
Porto Alegre RS 90610-000 Brazil
Pfizer Investigational Site
Sao Paulo SP 01509-900 Brazil
Pfizer Investigational Site
Sydney Nova Scotia B1P 1P3 Canada
Pfizer Investigational Site
Cali Colombia
Pfizer Investigational Site
Bogota Bogota . DC Colombia
Pfizer Investigational Site
Hyderabad Andhra Pradesh 500 082 India
Pfizer Investigational Site
Bangalore Karnataka 560 029 India
Pfizer Investigational Site
Mumbai Maharashtra 400 012 India
Pfizer Investigational Site
Pune Maharashtra 41101 India
Pfizer Investigational Site
Mexico Distrito Federal 07760 Mexico
Pfizer Investigational Site
Guadalajara Jalisco 44280 Mexico
Pfizer Investigational Site
Lima 11 Peru
Pfizer Investigational Site
Lima 34 Peru
Pfizer Investigational Site
Manila 1000 Philippines
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00038103
Study ID Number: NQ8-01-02-013
ClinicalTrials.gov Identifier: NCT00038103
Health Authority: United States: Food and Drug Administration
To obtain contact information for a study center near you, click here.
Clinical Trials Authorship and Review
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