Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Celecoxib; Exemestane; Tamoxifen

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