Conditions: Breast Cancer
Keywords: breast cancer breast cancer in situ ductal breast carcinoma in situ stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief 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.

Arms:
arm 1: This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.

Interventions: intervention 1: anastrozole intervention 2: simvastatin intervention 3: pharmacological study intervention 4: adjuvant therapy
Intervention descriptions: intervention 1: 1 milligram tablet PO QD for 14 days intervention 2: 40 milligram tablet PO QD for 14 days intervention 3: laboratory analysis intervention 4: laboratory analysis

Protocol document: