Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
Other: pharmacological study
Procedure: adjuvant therapy
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole|
- Change in Blood Concentrations [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]The change in blood concentrations of anastrozole at baseline and 14 days was measured.
- Change in Serum Estradiol Levels [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]The change in serum concentrations of estradiol at baseline and 14 days was measured.
|Study Start Date:||June 2006|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Anastrozole and Simvastatin
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
1 milligram tablet PO QD for 14 days
Other Name: ArimidexDrug: simvastatin
40 milligram tablet PO QD for 14 days
Other Name: ZocorOther: pharmacological study
laboratory analysisProcedure: adjuvant therapy
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354640
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Vered Stearns, MD||Sidney Kimmel Comprehensive Cancer Center|