Recruiting
Phase 2

Statins & Biomarkers

Sponsor:

University of Vermont

Code:

NCT00914017

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Not accepted

Interventions

Atorvastatin

Placebo

Study Details

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 (Lipitor™) or placebo for lowering mammography-defined breast density and other surrogate markers associated with breast cancer risk.

Conditions

Breast Cancer

Study ID

NCT00914017

Start date

Jan, 2005

Status verified date

Feb, 2010

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Atorvastatin

40 mg of Lipitor (atorvastatin) daily for 1 year

placebo comparator: Sugar Pill

Sugar pill daily for 1 year

Interventions

Atorvastatin

Atorvastatin, 40 mg daily for 1 year

Placebo

sugar pill daily for 1 year

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Fonda Kingsley, MHS

802-656-8502Fonda.Kingsley@UVM.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Ono Nyseo

415-885-7638onouwem.nseyo@ucsfmedctr.org

Principal Investigator:

Laura Esserman, MD

Delaware Christiana Care CCOP, Helen F. Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19718

Contacts

Pam Eppes

302-623-4125

Principal Investigator:

Stephen Grubbs, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Carleen Gentry

617-632-5399

Principal Investigator:

Judy Garber, MD, MPH

Southern Nevada Cancer Research Foundation

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Jennifer Eccles

702-384-0013

Principal Investigator:

John Ellerton, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Shelly Epps, MS

919-956-5644clark086@mc.duke.edu

Principal Investigator:

Victoria Seewaldt, MD

Southeastern Medical Oncology Center

Recruiting

Goldsboro, North Carolina, United States, 27534

Contacts

Monica Brimberry

919-580-0000monicab@cancersmoc.com

Principal Investigator:

James Atkins, MD

Vermont Cancer Center

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Fonda Kingsley, MHS

802-656-8502Fonda.Kingsley@uvm.edu

Principal Investigator:

Marie E Wood, MD

More Information

Sponsor

University of Vermont

Last update posted

Feb 11, 2010

Last verified

Feb, 2010

Keywords

  • Breast Cancer
  • Breast Cancer Prevention
  • Mammographic Density
  • Breast Density
  • Breast Cancer Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Vermont on 2010-02-11.