Breast Cancer Clinical Trial
Official title:
A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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