Statins and Breast Cancer Biomarkers

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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 less likely to get breast cancer. This ongoing randomized trial compares one-year of atorvastatin (Lipitor™) or placebo for lowering mammography-defined breast density and other surrogate markers associated with breast cancer risk.

Key facts

Study ID

NCT00914017

Run by

University of Vermont

People needed

100

Starts

2005-01-01

Last updated by the study team

2010-02-11

Who can join

Age: 35 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Delaware Christiana Care CCOP, Helen F. Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Southern Nevada Cancer Research Foundation — Las Vegas, Nevada, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Southeastern Medical Oncology Center — Goldsboro, North Carolina, United States (enrolling)
• Vermont Cancer Center — Burlington, Vermont, United States (enrolling)

Full record on ClinicalTrials.gov

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