A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer
OBJECTIVES: I. Determine the efficacy of letrozole, in terms of objective tumor response and
time to progression, in women with recurrent or metastatic endometrial cancer. II. Determine
the toxicity of letrozole in these patients. III. Determine the relationship between tumor
receptor status, histologic grade, tumor aromatase activity, and tumor response in these
OUTLINE: Patients receive an oral letrozole tablet daily. Treatment continues for patients
with complete or partial response until disease progression or unacceptable toxicity.
Patients with stable disease may discontinue therapy after 24 weeks. Patients are followed
at 1 month and then every 3 months until death.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study within 12-18 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumour response
Anthony Fyles, MD
Princess Margaret Hospital, Canada
United States: Federal Government