At a glance
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Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole
In Brief
A clinical study evaluating Letrozole for Breast Neoplasms. Completed, enrolled 121 participants across 3 sites.
Detailed Summary
The purpose of this study is to examine how key patient factors, including body size affect how well letrozole suppresses circulating estrogen levels. This study has two components: (1) Part A - an observational phase to evaluate the impact of vitamin D and obesity on estrogen suppression in post-menopausal women already receiving letrozole treatment, and (2) Part B - an interventional phase for women with body mass index (BMI) \> 25 kg/m2 to assess the effect of double AI dose on estrogen levels. If BMI or other patient factors reduce the effectiveness of letrozole, modifications to treatment recommendations and studies to test higher dosing of letrozole may be needed to maximize the benefit of this treatment and minimize the risk of the breast cancer coming back.
Study Details
Timeline
Interventions
Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.