A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
OBJECTIVES:
Primary
- 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.
Secondary
- Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in
these patients.
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.
Interventional
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
No
Vered Stearns, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
J05100, CDR0000485361
NCT00354640
June 2006
November 2011
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |