A Study of Letrozole in the Treatment of Endometrial Cancer

A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.

Inclusion criteria

• Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
• No adjuvant therapy
• Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
• No chemotherapy for recurrence (adjuvant permitted)
• Unidimensionally measurable disease
• Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
• No prior tamoxifen or aromatase inhibitor therapy
• No other concurrent anti-cancer treatment
• No metastases in the central nervous system

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria may apply