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Clinical Trial Name - Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having P
| Original Study ID : NQ8-01-02-013 |
| NCT ID : NCT00038103 |
| Brief Title : Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen |
| 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 |
| Brief Summary : 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. |
| Source : Pfizer |
| Overall Status : Completed |
| Start Date : January 2002 |
| End Date : March 2008 |
| Completion Date : March 2008 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 110 |
| Verification Date : September 2008 |
| First Received Date : May 29, 2002 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Pfizer Investigational Site |
| City : Dallas |
| State : Texas |
| Zip Code : 75204 |
| Country : United States |
| Facility Name : Pfizer Investigational Site |
| City : Leuven |
| State : Texas |
| Zip Code : 3000 |
| Country : Belgium |
| Facility Name : Pfizer Investigational Site |
| City : WILRIJK |
| State : Texas |
| Zip Code : 2610 |
| Country : Belgium |
| Facility Name : Pfizer Investigational Site |
| City : Antwerpen |
| State : Texas |
| Zip Code : 2020 |
| Country : Belgium |
| Facility Name : Pfizer Investigational Site |
| City : Bruxelles |
| State : Texas |
| Zip Code : 1000 |
| Country : Belgium |
| Facility Name : Pfizer Investigational Site |
| City : Namur |
| State : Texas |
| Zip Code : 5000 |
| Country : Belgium |
| Facility Name : Pfizer Investigational Site |
| City : Porto Alegre |
| State : RS |
| Zip Code : 90610-000 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Sao Paulo |
| State : SP |
| Zip Code : 01509-900 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Sydney |
| State : Nova Scotia |
| Zip Code : B1P 1P3 |
| Country : Canada |
| Facility Name : Pfizer Investigational Site |
| City : Cali |
| State : Nova Scotia |
| Zip Code : B1P 1P3 |
| Country : Colombia |
| Facility Name : Pfizer Investigational Site |
| City : Bogota |
| State : Bogota . DC |
| Zip Code : B1P 1P3 |
| Country : Colombia |
| Facility Name : Pfizer Investigational Site |
| City : Hyderabad |
| State : Andhra Pradesh |
| Zip Code : 500 082 |
| Country : India |
| Facility Name : Pfizer Investigational Site |
| City : Bangalore |
| State : Karnataka |
| Zip Code : 560 029 |
| Country : India |
| Facility Name : Pfizer Investigational Site |
| City : Mumbai |
| State : Maharashtra |
| Zip Code : 400 012 |
| Country : India |
| Facility Name : Pfizer Investigational Site |
| City : Pune |
| State : Maharashtra |
| Zip Code : 41101 |
| Country : India |
| Facility Name : Pfizer Investigational Site |
| City : Mexico |
| State : Distrito Federal |
| Zip Code : 07760 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : Guadalajara |
| State : Jalisco |
| Zip Code : 44280 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : Lima |
| State : Jalisco |
| Zip Code : 11 |
| Country : Peru |
| Facility Name : Pfizer Investigational Site |
| City : Lima |
| State : Jalisco |
| Zip Code : 34 |
| Country : Peru |
| Facility Name : Pfizer Investigational Site |
| City : Manila |
| State : Jalisco |
| Zip Code : 1000 |
| Country : Philippines |
| OutComes |
| Primary OutComes |
| Measure : clinical benefit (defined as the frequency of tumor response and disease stabilization for at least 24 weeks) |
| Time Frame : August 2003 |
| Safety issue : Yes |
| Secondary OutComes |
| Measure : Other efficacy parameters than clinical benefit; tolerability; PD and PK |
| Time Frame : June 2006 |
| Safety issue : Yes |
| Measure : Survival |
| Time Frame : December 2012 |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : Celecoxib |
| Description : Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food. If randomized to the exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food. |
| Type : Drug |
| Name : Exemestane |
| Description : Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food. If randomized to the exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food. |
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