A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
- Assess the effects of concurrent anastrozole and simvastatin on anastrozole's
steady-state concentration in postmenopausal women with history of invasive breast
cancer or ductal carcinoma in situ or at high risk for developing breast cancer.
- Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in
OUTLINE: This is a pilot study.
Patients continue to receive oral anastrozole once daily (as prior to study entry). They
also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable
toxicity or diagnosis of new or recurrent breast cancer.
Patients undergo blood sample collection at baseline and after study therapy for analysis of
anastrozole and hormone (estradiol and estrogen) concentrations.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in Blood Concentrations
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
Baseline and 14 days
Vered Stearns, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|