Status:
COMPLETED
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 bac...
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 ducta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00354640
Start Date
June 1 2006
End Date
November 1 2011
Last Update
June 24 2013
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410