Statins and Breast Cancer Biomarkers
Statins and Breast Cancer Biomarkers
This study is currently recruiting participants.
Study NCT00914017 Information provided by University of Vermont
First Received: June 2, 2009 Last Updated: June 9, 2009 History of Changes
Tracking Information
First Received Date ICMJE June 2, 2009
Last Updated Date June 9, 2009
Start Date ICMJE January 2005
Estimated Primary Completion Date December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE
(submitted: June 2, 2009) To evaluate change in percent mammographic density after one year of statin administration in pre-menopausal women at high risk for breast cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE Same as current
Change History Complete list of historical versions of study NCT00914017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE
(submitted: June 2, 2009) To evaluate changes in IGF1 levels after 12 months of statin administration in pre-menopausal women at high-risk for breast cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To correlate changes in breast density with changes in molecular markers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE Same as current
Descriptive Information
Brief Title ICMJE Statins and Breast Cancer Biomarkers
Official Title ICMJE Statins and Breast Cancer Biomarkers
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.
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 atorvastatin or placebo. The primary aim of this project is to determine the effect of atorvastatin on breast density, a known risk factor for breast cancer. In addition, the affect of atorvastatin on serum biomarkers (IGF1) and tissue biomarkers (atypia and Ki67) associated with risk is being evaluated.
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.
Study Phase Phase II
Study Type ICMJE Interventional
Study Design ICMJE Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition ICMJE Breast Cancer
Intervention ICMJE Drug: Atorvastatin
Atorvastatin, 40 mg daily for 1 year
Other Names:
Lipitor
statin
Drug: Placebo
sugar pill daily for 1 year
Study Arms / Comparison Groups Atorvastatin: Experimental
40 mg of Lipitor (atorvastatin) daily for 1 year
Intervention: Drug: Atorvastatin
Sugar Pill: Placebo Comparator
Sugar pill daily for 1 year
Intervention: Drug: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ICMJE Recruiting
Estimated Enrollment ICMJE 100
Completion Date
Estimated Primary Completion Date December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE Inclusion Criteria:
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 Criteria:
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
Gender Female
Ages 35 Years to 55 Years
Accepts Healthy Volunteers No
Contacts ICMJE Contact: Fonda Kingsley, MHS 802-656-8502 Fonda.Kingsley@UVM.edu
Location Countries ICMJE United States
Administrative Information
NCT ID ICMJE NCT00914017
Responsible Party Marie Wood, MD, Vermont Cancer Center at University of Vermont and Fletcher Allen Health Care
Study ID Numbers ICMJE V0407, CHRMS#: 05-059
Study Sponsor ICMJE University of Vermont
Collaborators ICMJE Breast Cancer Research Foundation
Cancer and Leukemia Group B
Investigators ICMJE Principal Investigator: Marie E Wood, MD University of Vermont
Information Provided By University of Vermont
Verification Date June 2009
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