Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2005-01-31
Brief Summary
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Detailed Description
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Because of their tolerability and safety, statins have a great potential as a breast cancer preventative agent. Should this pilot study show a significant decrease in breast density and/or change in serum and tissue biomarkers in statin treated patients these data would then be used to support a large randomized trial.
This is a multi-center, prospective, randomized placebo controlled clinical trial. Target enrollment is 100 women, with 50 receiving atorvastatin and 50 receiving a similar appearing placebo tablet. Eligible women must be at least 35 years old with regular menstrual cycles and a Gail Model risk of greater than 1.66% over 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Atorvastatin
40 mg of Lipitor (atorvastatin) daily for 1 year
Atorvastatin
Atorvastatin, 40 mg daily for 1 year
Sugar Pill
Sugar pill daily for 1 year
Placebo
sugar pill daily for 1 year
Interventions
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Atorvastatin
Atorvastatin, 40 mg daily for 1 year
Placebo
sugar pill daily for 1 year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
35 Years
55 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
Cancer and Leukemia Group B
NETWORK
University of Vermont
OTHER
Responsible Party
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Vermont Cancer Center at University of Vermont and Fletcher Allen Health Care
Principal Investigators
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Marie E Wood, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of California, San Francisco
San Francisco, California, United States
Delaware Christiana Care CCOP, Helen F. Graham Cancer Center
Newark, Delaware, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Duke University
Durham, North Carolina, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Vermont Cancer Center
Burlington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Pam Eppes
Role: primary
Carleen Gentry
Role: primary
Jennifer Eccles
Role: primary
Related Links
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High Risk Breast Program of Vermont, Research Studies
Other Identifiers
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CHRMS#: 05-059
Identifier Type: -
Identifier Source: secondary_id
V0407
Identifier Type: -
Identifier Source: org_study_id
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