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HMG-CoA reductase inhibitor

Statins for Breast Cancer

Phase 2
Waitlist Available
Led By Marie E Wood, MD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A germline mutation in BRCA1/2 in themselves or their family
A Gail Model Risk of > 1.67% over 5 years
Must not have
Women concurrently participating in another breast cancer chemoprevention trial
Women with underlying liver disease or abnormal liver studies including alkaline phosphatase, ALT, AST and Bilirubin (greater than 1.5 times normal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing whether the cholesterol-lowering medication atorvastatin can reduce the risk of breast cancer.

Who is the study for?
This trial is for pre-menopausal women over 35 with a history of certain breast conditions or at high risk for breast cancer, who have completed any previous cancer treatments at least a year ago. It's not for those with stage IV cancer, on hormone therapy, taking medications that interact poorly with statins, pregnant/breastfeeding women, participants in other chemoprevention trials, or those with liver disease.Check my eligibility
What is being tested?
The study tests if Atorvastatin (Lipitor™), a cholesterol-lowering drug, can reduce mammography-defined breast density and lower the risk of developing breast cancer compared to a placebo. Women are randomly assigned to receive either the drug or placebo for one year.See study design
What are the potential side effects?
Atorvastatin may cause muscle pain or weakness (myopathy), severe muscle breakdown (rhabdomyolysis), liver issues including abnormal liver studies such as increased enzymes and bilirubin levels. Allergic reactions to components of Atorvastatin are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I or a family member have a BRCA1/2 gene mutation.
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My breast cancer risk over the next 5 years is higher than 1.67%.
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I am 35 years old or older.
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My biopsy showed abnormal cell growth or LCIS.
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I am a pre-menopausal woman with regular periods over the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not in another breast cancer prevention trial.
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My liver function tests are higher than normal.
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I am allergic to atorvastatin or its ingredients.
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I am currently taking tamoxifen, raloxifene, or an aromatase inhibitor.
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I have had stage IV breast or ovarian cancer in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 correlate changes in breast density with changes in molecular markers.
To evaluate changes in IGF1 levels after 12 months of statin administration in pre-menopausal women at high-risk for breast cancer.
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.

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069
3%
Postoperative bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtorvastatinExperimental Treatment1 Intervention
40 mg of Lipitor (atorvastatin) daily for 1 year
Group II: Sugar PillPlacebo Group1 Intervention
Sugar pill daily for 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
FDA approved

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
272 Previous Clinical Trials
3,743,772 Total Patients Enrolled
9 Trials studying Breast Cancer
3,687,265 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
137,630 Total Patients Enrolled
41 Trials studying Breast Cancer
130,377 Patients Enrolled for Breast Cancer
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
117,888 Total Patients Enrolled
19 Trials studying Breast Cancer
30,676 Patients Enrolled for Breast Cancer

Media Library

Atorvastatin (HMG-CoA reductase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00914017 — Phase 2
Breast Cancer Research Study Groups: Sugar Pill, Atorvastatin
Breast Cancer Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT00914017 — Phase 2
Atorvastatin (HMG-CoA reductase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00914017 — Phase 2
~5 spots leftby Jul 2025
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