Statins and Breast Cancer Biomarkers

February 10, 2010 updated by: University of Vermont
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Delaware Christiana Care CCOP, Helen F. Graham Cancer Center
        • Contact:
          • Pam Eppes
          • Phone Number: 302-623-4125
        • Principal Investigator:
          • Stephen Grubbs, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Carleen Gentry
          • Phone Number: 617-632-5399
        • Principal Investigator:
          • Judy Garber, MD, MPH
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Southern Nevada Cancer Research Foundation
        • Contact:
          • Jennifer Eccles
          • Phone Number: 702-384-0013
        • Principal Investigator:
          • John Ellerton, MD
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center
        • Principal Investigator:
          • James Atkins, MD
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • Vermont Cancer Center
        • Contact:
        • Principal Investigator:
          • Marie E Wood, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year
To correlate changes in breast density with changes in molecular markers.
Time Frame: 1 year
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.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Cancer and Leukemia Group B
Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Marie E Wood, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2010

Last Update Submitted That Met QC Criteria

February 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V0407
  • CHRMS#: 05-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe