Statins and Breast Cancer Biomarkers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Vermont.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Breast Cancer Research Foundation
Cancer and Leukemia Group B
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00914017
First received: June 2, 2009
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Atorvastatin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Statins and Breast Cancer Biomarkers

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: January 2005
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
40 mg of Lipitor (atorvastatin) daily for 1 year
Drug: Atorvastatin
Atorvastatin, 40 mg daily for 1 year
Other Names:
  • Lipitor
  • statin
Placebo Comparator: Sugar Pill
Sugar pill daily for 1 year
Drug: Placebo
sugar pill daily for 1 year

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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914017

Contacts
Contact: Fonda Kingsley, MHS 802-656-8502 Fonda.Kingsley@UVM.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Ono Nyseo    415-885-7638    onouwem.nseyo@ucsfmedctr.org   
Principal Investigator: Laura Esserman, MD         
United States, Delaware
Delaware Christiana Care CCOP, Helen F. Graham Cancer Center Recruiting
Newark, Delaware, United States, 19718
Contact: Pam Eppes    302-623-4125      
Principal Investigator: Stephen Grubbs, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carleen Gentry    617-632-5399      
Principal Investigator: Judy Garber, MD, MPH         
United States, Nevada
Southern Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jennifer Eccles    702-384-0013      
Principal Investigator: John Ellerton, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Shelly Epps, MS    919-956-5644    clark086@mc.duke.edu   
Principal Investigator: Victoria Seewaldt, MD         
Southeastern Medical Oncology Center Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: Monica Brimberry    919-580-0000 ext 138    monicab@cancersmoc.com   
Principal Investigator: James Atkins, MD         
United States, Vermont
Vermont Cancer Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Fonda Kingsley, MHS    802-656-8502    Fonda.Kingsley@uvm.edu   
Principal Investigator: Marie E Wood, MD         
Sponsors and Collaborators
University of Vermont
Breast Cancer Research Foundation
Cancer and Leukemia Group B
Investigators
Principal Investigator: Marie E Wood, MD University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: Marie Wood, MD, Vermont Cancer Center at University of Vermont and Fletcher Allen Health Care
ClinicalTrials.gov Identifier: NCT00914017     History of Changes
Other Study ID Numbers: V0407, CHRMS#: 05-059
Study First Received: June 2, 2009
Last Updated: February 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Breast Cancer
Breast Cancer Prevention
Mammographic Density
Breast Density
Breast Cancer Biomarkers

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014