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Statins and Breast Cancer Biomarkers

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Breast Cancer Prevention, Mammographic Density, Breast Density, Breast Cancer Biomarkers

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San FranciscoRecruiting
  • Delaware Christiana Care CCOP, Helen F. Graham Cancer CenterRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Southern Nevada Cancer Research FoundationRecruiting
  • Duke UniversityRecruiting
  • Southeastern Medical Oncology CenterRecruiting
  • Vermont Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Sugar Pill

Arm Description

40 mg of Lipitor (atorvastatin) daily for 1 year

Sugar pill daily for 1 year

Outcomes

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.

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.
To correlate changes in breast density with changes in molecular markers.
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.

Full Information

First Posted
June 2, 2009
Last Updated
February 10, 2010
Sponsor
University of Vermont
Collaborators
Breast Cancer Research Foundation, Cancer and Leukemia Group B
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1. Study Identification

Unique Protocol Identification Number
NCT00914017
Brief Title
Statins and Breast Cancer Biomarkers
Official Title
Statins and Breast Cancer Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Vermont
Collaborators
Breast Cancer Research Foundation, Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Breast Cancer Prevention, Mammographic Density, Breast Density, Breast Cancer Biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
40 mg of Lipitor (atorvastatin) daily for 1 year
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Sugar pill daily for 1 year
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor, statin
Intervention Description
Atorvastatin, 40 mg daily for 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sugar pill daily for 1 year
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To correlate changes in breast density with changes in molecular markers.
Time Frame
1 year
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fonda Kingsley, MHS
Phone
802-656-8502
Email
Fonda.Kingsley@UVM.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie E Wood, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ono Nyseo
Phone
415-885-7638
Email
onouwem.nseyo@ucsfmedctr.org
First Name & Middle Initial & Last Name & Degree
Laura Esserman, MD
Facility Name
Delaware Christiana Care CCOP, Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Eppes
Phone
302-623-4125
First Name & Middle Initial & Last Name & Degree
Stephen Grubbs, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carleen Gentry
Phone
617-632-5399
First Name & Middle Initial & Last Name & Degree
Judy Garber, MD, MPH
Facility Name
Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Eccles
Phone
702-384-0013
First Name & Middle Initial & Last Name & Degree
John Ellerton, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Epps, MS
Phone
919-956-5644
Email
clark086@mc.duke.edu
First Name & Middle Initial & Last Name & Degree
Victoria Seewaldt, MD
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Brimberry
Phone
919-580-0000
Ext
138
Email
monicab@cancersmoc.com
First Name & Middle Initial & Last Name & Degree
James Atkins, MD
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fonda Kingsley, MHS
Phone
802-656-8502
Email
Fonda.Kingsley@uvm.edu
First Name & Middle Initial & Last Name & Degree
Marie E Wood, MD

12. IPD Sharing Statement

Links:
URL
http://hrbp.vermontcancer.org/?page_id=4
Description
High Risk Breast Program of Vermont, Research Studies

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Statins and Breast Cancer Biomarkers

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