A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density

OBJECTIVES:

Primary

• Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole for 1 year.

Secondary

• Determine whether a decrease in breast density grade is sustained at 1 year in patients treated with this drug.
• Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline in these patients.
• Determine the percentage of patients with breast tissue hyperplasia and atypical hyperplasia, as assessed by histopathological examination of breast tissue biopsies, before and after treatment with this drug.
• Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after cessation of this drug in these patients.
• Compare changes in predetermined specific parameters of safety at the end of 1 year of treatment with this drug with baseline evaluations of these patients.
• Determine whether modifications of these predetermined specific parameters of safety are sustained 1 year after cessation of treatment with this drug in these patients.
• Determine the general safety of 1 year of treatment with this drug in these patients.
• Compare the effects of this drug on menopause-specific quality of life of these patients.