A Trial of Exemestane in Postmenopausal Women With DCIS or at High Risk for Invasive Breast Cancer
Evidence from adjuvant treatment trials of invasive breast cancer with aromatase inhibitors
suggests that these agents are superior to tamoxifen in preventing contralateral breast
cancer and are well tolerated. These agents are promising breast cancer chemopreventive
agents. Data on safety and effect on surrogate biomarkers in a healthy at risk population is
-The primary objective is to evaluate the study drug effects on mammographic density after
one year on treatment.
-Secondary objectives include assessing the effect of the intervention on bone mineral
density, serum hormones and lipids, and breast tissue biomarkers.
Eligible patients are postmenopausal women who meet one of the following criteria:
- History of stage I or II breast cancer 2 years out from definitive therapy.
- Gail model 5 year risk greater than or equal to 1.7%
- History of treated DCIS
- History of high risk lesion on breast biopsy (ADH, ALH, LCIS)
- Known or suspected BRCA1 or BRCA2 mutation
- Subjects must have adequate bone mineral density by DEXA scan in order to enroll.
- This is an open label study of exemestane in postmenopausal women with an elevated risk
of developing invasive breast cancer. Forty five subjects will be enrolled and receive
standard dose exemestane (25 mg QD), calcium and vitamin D.
- Each subject will continue treatment for a total of two years.
- Changes in mammographic breast density and bone mineral density will be evaluated
annually which will provide long term biomarker and safety information about prevention
therapy with exemestane.
Masking: Open Label, Primary Purpose: Prevention
Effect of exemestane on mammographic density at 1 year
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|