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

Johns Hopkins Medicine

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Other: pharmacological study

Procedure: adjuvant therapy

Drug: simvastatin

Drug: anastrozole

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00354640

J05100, CDR0000485361

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-SKCCC-J05100 (Other Identifier)

JHOC-J05100 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Meets any of the following criteria:
- History of invasive breast cancer
- History of ductal carcinoma in situ
- At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer
Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer
No active breast cancer with known metastatic involvement
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Postmenopausal
ECOG performance status 0-2
AST and ALT ≤ 3 times upper limit of normal
Creatinine clearance ≥ 30 mL/min
No active liver disease
No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components
No daily alcohol use of > 3 standard drinks/day
- A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No cholesterol-lowering drug, including a statin, within the past 3 months
No selective estrogen receptor modulator (SERM) within the past 3 months
No other hormone therapy within the past 3 months
No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years
- Vaginal estrogen preparations allowed
No other concurrent statin or cholesterol-lowering drug
No other concurrent SERM
No other concurrent hormone therapy
No other concurrent investigational drugs
No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine
No concurrent chemotherapy or biological agents
No concurrent daily grapefruit juice > 8 oz/day
No other concurrent anticancer agents or therapies