Statins and Breast Cancer Biomarkers
2 other identifiers
interventional
100
1 country
7
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 less likely to get breast cancer. This ongoing randomized trial compares one-year of atorvastatin (Lipitorâ„¢) or placebo for lowering mammography-defined breast density and other surrogate markers associated with breast cancer risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedFebruary 11, 2010
February 1, 2010
5.9 years
June 2, 2009
February 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate change in percent mammographic density after one year of statin administration in pre-menopausal women at high risk for breast cancer.
1 year
Secondary Outcomes (3)
To evaluate changes in IGF1 levels after 12 months of statin administration in pre-menopausal women at high-risk for breast cancer.
1 year
To correlate changes in breast density with changes in molecular markers.
1 year
To explore changes in breast duct cell cytology in a subset of patients after 12 months of statin administration in a subset of the trial population.
1 year
Study Arms (2)
Atorvastatin
EXPERIMENTAL40 mg of Lipitor (atorvastatin) daily for 1 year
Sugar Pill
PLACEBO COMPARATORSugar pill daily for 1 year
Interventions
Eligibility Criteria
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
- +2 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Vermontlead
- Breast Cancer Research Foundationcollaborator
- Cancer and Leukemia Group Bcollaborator
Study Sites (7)
University of California, San Francisco
San Francisco, California, 94143, United States
Delaware Christiana Care CCOP, Helen F. Graham Cancer Center
Newark, Delaware, 19718, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Duke University
Durham, North Carolina, 27705, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Vermont Cancer Center
Burlington, Vermont, 05405, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie E Wood, MD
University of Vermont
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 4, 2009
Study Start
January 1, 2005
Primary Completion
December 1, 2010
Last Updated
February 11, 2010
Record last verified: 2010-02