← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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

Select...

I or a family member have a BRCA1/2 gene mutation.

Select...

My breast cancer risk over the next 5 years is higher than 1.67%.

Select...

I am 35 years old or older.

Select...

My biopsy showed abnormal cell growth or LCIS.

Select...

I am a pre-menopausal woman with regular periods over the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Postoperative bleeding

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor

266 Previous Clinical Trials

3,743,591 Total Patients Enrolled

9 Trials studying Breast Cancer

3,687,265 Patients Enrolled for Breast Cancer

Breast Cancer Research FoundationOTHER

68 Previous Clinical Trials

137,543 Total Patients Enrolled

40 Trials studying Breast Cancer

130,253 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patient population is this clinical trial meant for?

"This clinical trial is only admitting women aged 35-55 that have breast cancer. They are looking for around 100 participants in total."

Answered by AI

What is the primary use that Atorvastatin has been FDA approved for?

"Atorvastatin is most often used to manage lipidemias, but it can also help patients who have postoperative thromboembolism, anginal pain, and transient ischemic attack."

Answered by AI

Has the Food and Drug Administration accepted Atorvastatin?

"Since this is a Phase 2 trial, there is only data supporting safety, not efficacy. As such, our team has given Atorvastatin a score of 2."

Answered by AI

Are there any patients presently enrolled in this clinical trial?

"According to the latest information from clinicaltrials.gov, this particular trial is not looking for patients at this time. This study was originally posted on January 1st, 2005 but hasn't been updated since February 10th, 2010. Although this research isn't currently recruiting people, there are 2,771 other trials that are actively searching for participants right now."

Answered by AI

Are there different hospitals or research centers participating in this trial across the state?

"There are 7 study sites for this research project, which are located in cities such as San Francisco, Las Vegas and Newark. If you want to enroll, it would be advantageous to choose the location nearest you to limit travel."

Answered by AI

How many test subjects are in this experiment?

"This particular study is no longer recruiting patients for participation. The trial was initially posted on 1/1/2005 and was most recently edited on 2/10/2010. However, there are presently 2698 clinical trials actively admitting patients with breast cancer and 73 trials for Atorvastatin that are still looking for participants."

Answered by AI

Is this research project only enrolling seniors?

"The aim of this study is to enroll patients that are 35-55 years old."

Answered by AI

What is Atorvastatin's clinical trial history?

"The first clinical trial for atorvastatin was completed in 2005 and hosted by OHSU Hospital. Since then, a total of 18669 clinical trials have been completed globally. There are 73 active studies recruiting patients as of now, with many taking place in San Francisco, California."

Answered by AI

What makes this experiment unique compared to others like it?

"Atorvastatin has been researched since 2005, when the first study was completed and sponsored by Merck Sharp & Dohme LLC. The initial trial involved 80 participants. Since then, there have been 73 live trials for Atorvastatin across 162 cities and 28 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Statins and Breast Cancer Biomarkers

2005. "Statins and Breast Cancer Biomarkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00914017.

All > North Carolina > Breast