Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00354640|
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: simvastatin Other: pharmacological study Procedure: adjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||November 2011|
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
- Change in Blood Concentrations [ Time Frame: Baseline and 14 days ]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 ]The change in serum concentrations of estradiol at baseline and 14 days was measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|