Statins for Breast Cancer

Recruiting at 12 trial locations

Overseen By Mridula George, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Statins, CYP 3A4 inhibitors

Disqualifiers: Stage IV cancer, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 5 years

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding Lipitor, a statin medication, can reduce treatment delays or early stops due to heart-related side effects in women receiving anti-HER2 therapy for Stage I-III HER2 positive breast cancer. Participants will take Lipitor daily alongside their cancer treatment to assess its potential heart-protective effects. Women with confirmed Stage I-III breast cancer, who are scheduled to start HER2 targeted therapy and have no history of heart issues, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking statins or CYP 3A4 inhibitors. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that statins, such as Lipitor, are usually well-tolerated by people with breast cancer. Studies have found a link between statin use and better survival rates for breast cancer patients. Some reports even suggest a 15% lower risk of death from breast cancer for those taking statins.

These findings highlight the benefits and suggest the safety of statins. The FDA has already approved statins for treating high cholesterol, indicating they have passed strict safety tests for that use.

In this trial, participants take Lipitor along with anti-HER2 therapy for breast cancer. The trial phase indicates that researchers are still collecting safety data for this specific combination. However, given the existing safety record of statins, the treatment is likely to be well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about using Lipitor, a statin typically used for managing cholesterol, as a treatment for breast cancer because it works differently from traditional chemotherapy or hormone therapies. Most treatments for breast cancer, like anti-HER2 therapies, target specific proteins or hormones to stop cancer growth. Lipitor, on the other hand, may interrupt the cancer's ability to grow by affecting cholesterol pathways, potentially enhancing the effectiveness of existing therapies. This unique mechanism could offer a new way to tackle breast cancer, providing hope for improved outcomes.

What evidence suggests that Lipitor might be an effective treatment for reducing cardiotoxicity in breast cancer patients?

Research has shown that statins, such as Lipitor, might reduce heart-related side effects in breast cancer patients receiving HER2-targeted therapy. In this trial, participants will take Lipitor 40 mg daily alongside anti-HER2 therapy. One study found that statin use was linked to better survival rates in patients with early-stage HER2-positive breast cancer. Another study demonstrated that adding statins enhanced the effectiveness of HER2 treatments. Statins have also been associated with a lower risk of breast cancer recurrence and a reduced chance of death from the disease. These findings suggest that Lipitor could help manage treatment side effects and improve outcomes for breast cancer patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Mridula George, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for women over 18 with Stage I-III HER2 positive breast cancer who haven't had HER2 therapy or anthracycline chemo before. They must have good heart, liver, and kidney function, no recent major surgery or significant diseases that could affect the study's safety. Participants can't be on statins already, have stage IV cancer, uncontrolled blood pressure, active liver disease or certain infections.

Inclusion Criteria

I agree to use effective birth control during my treatment.

My kidney function is within the required range.

I am scheduled for treatment targeting HER2 before/after surgery.

Exclusion Criteria

I am allergic to one or more of the drugs used in this study.

I currently have an active infection.

I do not have any health issues that would stop me from joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lipitor 40 mg daily while receiving anti-HER2 therapy

5 years

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Quality of Life questionnaires at baseline, 6, 12, and 15 months

What Are the Treatments Tested in This Trial?

Interventions

• Lipitor 40mg Tablet
• Lipitor 40Mg Tablet

Trial Overview The trial tests if Lipitor (40mg tablet) reduces treatment delays/discontinuations due to heart damage in patients receiving anti-HER2 therapy for early-stage breast cancer. It aims to see if adding a statin can protect the heart during such treatments.

How Is the Trial Designed?

Group I: Anti-HER2 targeted therapy + Lipitor 40mg daily Experimental Treatment 1 Intervention

Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

A systematic review of 26 mouse model studies indicates that statins exhibit antineoplastic effects in breast cancer, both as standalone treatments and in combination with other therapies.

Key factors such as the timing, dosage, and specific subtype of breast cancer are crucial for optimizing the use of statins in future clinical applications for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Link Between Statins and Breast Cancer in Mouse Models: A Systematic Review. Watson, R., Tulk, A., Erdrich, J.[2023]

Atorvastatin, marketed as Lipitor, is a highly effective statin that lowers LDL cholesterol and triglyceride levels by inhibiting the enzyme HMG-CoA reductase, which is crucial for cholesterol production.

It is primarily used to treat primary hypercholesterolemia or combined hyperlipidemia after dietary changes have failed, with typical doses starting at 10 mg daily and potentially increasing to 80 mg in severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug clinics. Drug of the month. Atorvastatin (Lipitor)]. Scheen, AJ.[2018]

Statins, such as atorvastatin and simvastatin, are effective cholesterol-lowering medications that have been widely prescribed, with over 70 million prescriptions for atorvastatin alone in 2004.

Current evidence indicates that statins do not significantly increase or decrease the risk of breast cancer, but further research is necessary to fully understand the long-term effects of statin therapy on breast cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statins and breast cancer: a smoking gun or guilt by association? Ahmed, MH., Osman, MM., Alokail, MS.[2019]

In a study involving 1,049 patients with moderate hypercholesterolemia, atorvastatin demonstrated a significantly greater reduction in LDL cholesterol and other lipid markers compared to lovastatin after 52 weeks, indicating its superior efficacy.

Atorvastatin was well tolerated, with a similar safety profile to lovastatin, and more patients on atorvastatin reached LDL cholesterol target levels, especially those with coronary heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of one-year efficacy and safety of atorvastatin versus lovastatin in primary hypercholesterolemia. Atorvastatin Study Group I. Davidson, M., McKenney, J., Stein, E., et al.[2019]

A meta-analysis of 17 cohort studies involving 168,700 women with breast cancer found that statin use is significantly associated with a lower risk of breast cancer recurrence (hazard ratio of 0.72) and reduced breast cancer mortality (hazard ratio of 0.80).

The analysis indicated that statins were particularly effective in reducing recurrence in studies with a follow-up duration of 5 years or less, showing a hazard ratio of 0.55, suggesting that the timing of statin use may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Statin Use and Prognosis of Breast Cancer: A Meta-Analysis of Cohort Studies. Lv, H., Shi, D., Fei, M., et al.[2020]

In a study of 1523 women with operable breast cancer, long-term statin use (more than 5 years) was associated with significantly improved overall survival (OS) and disease-free survival (DFS), suggesting a potential benefit of prolonged statin therapy in breast cancer outcomes.

The analysis indicated that even after adjusting for other health conditions, long-term statin users had a 62% lower risk of death and a 85% lower risk of disease recurrence, with trends showing benefits across various breast cancer subtypes, including triple-negative breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of long-term lipid-lowering therapy on clinical outcomes in breast cancer. Li, YR., Ro, V., Steel, L., et al.[2019]

In a study of 21,152 colorectal cancer patients, statin use was not linked to a reduced risk of cancer recurrence, indicating that statins do not provide a direct benefit in preventing cancer from coming back.

However, statin use was associated with a significant reduction in cancer-specific mortality and overall mortality, suggesting that while they may not help with recurrence, they could improve survival rates in colorectal cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Statin Use With Colorectal Cancer Recurrence and Mortality in a Danish Cohort. Lash, TL., Riis, AH., Ostenfeld, EB., et al.[2022]

Lipophilic statins demonstrated direct anticancer effects on breast cancer cells in vitro, particularly in cells with activated Ras or ErbB2 pathways, by inhibiting key signaling pathways that promote cell proliferation and survival.

In vivo studies in a mouse model of ErbB2(+) breast cancer showed that oral administration of statins significantly inhibited tumor growth, suggesting that statins could be a promising treatment option for certain breast cancer phenotypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer growth prevention by statins. Campbell, MJ., Esserman, LJ., Zhou, Y., et al.[2022]

In a study using rat models, atorvastatin and lovastatin did not significantly reduce the incidence of estrogen receptor-positive mammary cancers, indicating limited efficacy in cancer prevention.

While statins did not enhance the effectiveness of tamoxifen or bexarotene in reducing cancer multiplicity, they were able to lower triglyceride levels in bexarotene-treated rats, suggesting a potential role in managing lipid levels rather than directly preventing cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of efficacy of the statins atorvastatin and lovastatin in rodent mammary carcinogenesis. Lubet, RA., Boring, D., Steele, VE., et al.[2018]

In a study involving 63 high-risk premenopausal women, atorvastatin did not significantly affect mammographic density (MD), a known breast cancer risk biomarker, after one year of treatment.

While atorvastatin effectively reduced cholesterol and low-density lipoprotein (LDL) levels, it was associated with a significant increase in serum insulin growth factor 1 (IGF-1), suggesting that further research is needed to understand the implications of statin use in breast cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Atorvastatin on Breast Cancer Biomarkers in High-Risk Women. Ji, Y., Rounds, T., Crocker, A., et al.[2018]

A meta-analysis of 14 studies involving 75,684 women found that statin use is associated with improved recurrence-free survival (RFS) in breast cancer patients, particularly with lipophilic statins, which showed a significant hazard ratio (HR) of 0.64.

Statin users also demonstrated improved overall survival and cancer-specific survival, suggesting that statins may have beneficial effects in breast cancer treatment, although further research is needed to confirm these findings and identify optimal treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of statin use on cancer recurrence and mortality in breast cancer: A systematic review and meta-analysis. Manthravadi, S., Shrestha, A., Madhusudhana, S.[2022]

In a study of 240 Indian patients with atherosclerotic dyslipidemia, both 40mg and 80mg doses of atorvastatin were found to be equally effective in reducing LDL cholesterol levels over a 6-month period.

However, the higher 80mg dose was associated with a significantly greater incidence of myalgia, indicating a potential safety concern despite similar efficacy between the two doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To study the effect of high dose Atorvastatin 40mg versus 80mg in patients with dyslipidemia. Agrawal, D., Manchanda, SC., Sawhney, JPS., et al.[2020]

In a study of 3,227 patients taking 40 mg of atorvastatin daily for an average of 38 days, only 1.6% discontinued due to adverse effects, primarily mild issues like increased liver enzymes and muscle pain, indicating good safety and tolerability.

No serious side effects like rhabdomyolysis were reported, suggesting that atorvastatin is a safe option for managing cholesterol levels in various patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the use of atorvastatin 40 mg in common daily practice in short-term observation in 3,227 patients. Wiliński, J., Dabrowski, M.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10757972/

Impact of statin use on breast cancer recurrence and mortality ... Our findings suggest a beneficial effect of statins, both prior to and after diagnosis, in reducing overall mortality, breast cancer-specific mortality, and the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0925443924004514

Additional statin treatment enhances the efficacy of HER2 ... Consistently, retrospective analysis showed a longer recurrence-free survival in Rac1-high/HER2-positive BC patients treated with HER2-targeting agents with ...

3. nature.com nature.com/articles/s41598-024-67706-2

Atorvastatin lowers breast cancer risk by reversing an early ... Intriguingly, the data indicated that statin users were significantly less likely to develop breast cancer (OR 0.49; 95% CI 0.38–0.62, p = < ...

4. link.springer.com link.springer.com/article/10.1007/s10549-025-07699-2

Association of statin use on survival outcomes of patients ... We explored the association between statin use and survival outcomes in early HER2-positive breast cancer patients in the phase III APHINITY trial.

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-08258

A Statin (Atorvastatin Calcium) for the Reduction of Cardiac ... This phase II trial tests whether atorvastatin calcium works to reduce cardiac toxicity in patients with stage I-III breast cancer receiving HER2 targeted ...

6. nature.com nature.com/articles/s41416-025-03070-w

Statin use and breast cancer-specific mortality ... In this meta-analysis, we observed that statin use, particularly lipophilic statin use, was associated with favourable outcomes for BCD and BCR.

7. fredhutch.org fredhutch.org/en/news/spotlight/2024/06/exploring-the-potential-of-statins-in-reducing-breast-cancer-mor.html

Exploring the potential of statins in reducing breast cancer ... It, however, indicated that the risk of death from breast cancer was lower by 15% among female statin users. More in-depth analysis showed that ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00914017

NCT00914017 | Statins and Breast Cancer Biomarkers Clinical studies are controversial but some show that women taking statins are less likely to get breast cancer. This ongoing randomized trial ...