Breast CancerPhase 2NCT00914017
Statins and Breast Cancer Biomarkers
A Phase 2 study testing Atorvastatin in people with Breast Cancer, run by University of Vermont at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2005to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Carleen Gentry, 617-632-5399
Judy Garber, MD, MPH
- Recruiting
Vermont Cancer Center
Burlington, Vermont, 05405
Fonda Kingsley, MHS, 802-656-8502, Fonda.Kingsley@uvm.edu
Marie E Wood, MD
- Recruiting
Duke University
Durham, North Carolina, 27705
Shelly Epps, MS, 919-956-5644, clark086@mc.duke.edu
Victoria Seewaldt, MD
- Recruiting
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
Monica Brimberry, 919-580-0000 ext. 138, monicab@cancersmoc.com
James Atkins, MD
- Recruiting
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Jennifer Eccles, 702-384-0013
John Ellerton, MD
- Recruiting
Delaware Christiana Care CCOP, Helen F. Graham Cancer Center
Newark, Delaware, 19718
Pam Eppes, 302-623-4125
Stephen Grubbs, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Ono Nyseo, 415-885-7638, onouwem.nseyo@ucsfmedctr.org
Laura Esserman, MD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Atorvastatin, Placebo
- Keywords
- Breast Cancer, Breast Cancer Prevention, Mammographic Density, Breast Density, Breast Cancer Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor, statin
Atorvastatin, 40 mg daily for 1 year
PlaceboDrug
sugar pill daily for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 40 mg of Lipitor (atorvastatin) daily for 1 year Receives: Drug: Atorvastatin |
| Sugar Pill | Placebo comparator | Sugar pill daily for 1 year Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate change in percent mammographic density after one year of statin administration in pre-menopausal women at high risk for breast cancer.
Measured: 1 year
Secondary outcomes (3)
To evaluate changes in IGF1 levels after 12 months of statin administration in pre-menopausal women at high-risk for breast cancer.
Measured: 1 year
To correlate changes in breast density with changes in molecular markers.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJan 2005
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation, Cancer and Leukemia Group B
- Investigators
- Marie E Wood, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914017
- Sponsor's protocol ID
- V0407
- Other IDs
- CHRMS#: 05-059
- Status last verified
- Feb 2010
- First submitted
- 2 Jun 2009
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and Breast Cancer Biomarkers
- ClinicalTrials.gov ID
- NCT00914017
- Acronym / sponsor ID
- V0407
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Cancer Prevention, Mammographic Density, Breast Density, Breast Cancer Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation, Cancer and Leukemia Group B
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (estimated)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin40 mg of Lipitor (atorvastatin) daily for 1 year |
| Sugar Pill | Placebo comparator | Drug: PlaceboSugar pill daily for 1 year |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor, statinAtorvastatin, 40 mg daily for 1 year | Drug | Atorvastatin |
| Placebosugar pill daily for 1 year | Drug | Sugar Pill |
Primary outcome
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
3 secondary outcomes
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
To correlate changes in breast density with changes in molecular markers.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
- High Risk Breast Program of Vermont, Research StudiesLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie E Wood, MD principal investigator
University of Vermont
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Breast Cancer, run by University of Vermont at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fonda Kingsley, MHS (802-656-8502, Fonda.Kingsley@UVM.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2010.