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

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

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.

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