Status:
UNKNOWN
Statins and Breast Cancer Biomarkers
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Breast Cancer Research Foundation
Cancer and Leukemia Group B
Conditions:
Breast Cancer
Eligibility:
FEMALE
35-55 years
Phase:
PHASE2
Brief Summary
There is laboratory evidence that cholesterol lowering medications (statins) inhibit the growth of breast cancer cells. Clinical studies are controversial but some show that women taking statins are l...
Detailed Description
This project was designed to evaluate the effect of a specific statin (atorvastatin) on several breast cancer biomarkers. One hundred women will be treated for one year with either 40 mg of atorvastat...
Eligibility Criteria
Inclusion
- Women willing and able to give written informed consent
- Pre-menopausal women with regular menstrual cycles (4 cycles in the past 6 months)
- At least 35 years of age
- Women at increased risk of developing breast cancer, defined as at least one of the following four criteria:
- Having had a biopsy demonstrating atypical hyperplasia or lobular neoplasia/LCIS
- A germline mutation in BRCA1/2 in themselves or their family.
- A Gail Model Risk of \> 1.67% over 5 years
- A strong family history of breast and/or ovarian cancer which is defined as at least one of the following:
- One first-degree relative with breast cancer before the age of 50 years
- One first degree relative with bilateral breast cancer
- Two or more first-degree relatives with breast cancer
- One first degree relative and two or more second or third degree relatives with breast cancer
- One first-degree relative with breast cancer and one or more relatives with ovarian cancer
- Two second or third degree relatives with either breast cancer and one or more with ovarian cancer
- One second or third degree relative with breast cancer and two or more with ovarian cancer
- Three or more second or third degree relatives with breast cancer
- A prior history of breast cancer, including DCIS and stage 0-IIIb, and are at least one year off of all therapy (including radiation, biologic, hormonal and/or chemotherapy)
Exclusion
- Women with a prior history of stage IV breast cancer or ovarian cancer
- Women already taking statins. Women previously on statins may participate if they have not taken any statins in the six months prior to study entry
- Women concurrently participating in another breast cancer chemoprevention trial
- Women taking hormone replacement therapy (estrogen and progesterone; topical estrogen will be allowed)
- Women taking tamoxifen, raloxifene, or an aromatase inhibitor
- Women taking drugs that increase risk of statin induced myopathy or rhabdomyolysis (i.e., Niacin, protease inhibitors, verapamil, gemfibrozil, cyclosporine, clofibrate/fenofibrate or any CYP3A4 inhibitor)
- Women with underlying liver disease or abnormal liver studies including:
- alkaline phosphatase, ALT, AST and Bilirubin (greater than 1.5 times normal)
- Women who have had hypersensitivity to atorvastatin or any component of the formulation
- Women who are pregnant, planning pregnancy within the next year, or breastfeeding
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00914017
Start Date
January 1 2005
Last Update
February 11 2010
Active Locations (7)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Delaware Christiana Care CCOP, Helen F. Graham Cancer Center
Newark, Delaware, United States, 19718
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106