A Study of Letrozole in the Treatment of Endometrial Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Recurrent and Metastatic Endometrial Cancer

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00333086

CFEM345ADE03

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)