NCT00354640

Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	anastrozole	1 milligram tablet PO QD for 14 days
DRUG	simvastatin	40 milligram tablet PO QD for 14 days
OTHER	pharmacological study	laboratory analysis
PROCEDURE	adjuvant therapy	laboratory analysis

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-10-01
• Completion: 2011-11-01
• First posted: 2006-07-20
• Last updated: 2013-06-24
• Results posted: 2013-06-24

Locations

1 site across 1 country: United States