Low-Dose Aspirin for Breast Cancer Prevention

Recruiting at 2 trial locations

Overseen By Clinical Trials Referral Office

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: NSAIDs, Anticoagulants

Disqualifiers: Breast cancer, Other cancer, Post-menopausal, 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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6-9 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether low-dose aspirin can reduce inflammation markers in postpartum women, potentially lowering the risk of breast cancer after childbirth. Researchers are exploring how aspirin, a common anti-inflammatory drug, might impact blood and tissue inflammation. Women who have given birth within the last 10 years and are planning a breast biopsy might be suitable candidates for this trial. Participants will take aspirin daily and undergo blood tests to monitor changes. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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

Yes, you must stop taking aspirin, other NSAIDs, and anticoagulants before joining the trial. Specifically, you should not have taken any doses of these medications within 5 days prior to registration and no more than four doses within 30 days prior to registration.

Is there any evidence suggesting that low-dose aspirin is likely to be safe for humans?

Research shows that low-dose aspirin is usually safe for most people. Studies have found that taking low-dose aspirin daily can reduce the risk of certain cancers, such as breast cancer. Specifically, individuals who took low-dose aspirin daily were less likely to experience cancer recurrence compared to those who did not.

However, caution is necessary. People with low body weight might face a higher risk of sudden death when using aspirin, and some individuals may have an increased chance of bleeding. Despite these risks, using low-dose aspirin for at least five years often provides more benefits than harms.

In summary, while risks exist, many studies suggest that low-dose aspirin can be safely taken long-term. Always consult a healthcare provider to determine if it's appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using low-dose aspirin for breast cancer prevention because it offers a simple, non-invasive approach that differs from the usual preventive measures like lifestyle changes and medications such as selective estrogen receptor modulators (SERMs). Aspirin is widely known for its anti-inflammatory properties, which may play a role in reducing cancer risk by curbing inflammation that can lead to cancer development. Additionally, the use of a low dose minimizes potential side effects, making it a potentially safer option for long-term use compared to more aggressive treatments. This approach could provide an accessible and cost-effective strategy for reducing breast cancer risk.

What evidence suggests that low-dose aspirin might be an effective treatment for postpartum related breast cancer?

Research has shown that low-dose aspirin might help reduce swelling in breast tissue. One study found that regular aspirin use lowered the risk of dying from breast cancer. Another study demonstrated that low-dose aspirin can decrease swelling in breast tissue, which is crucial because long-term swelling can raise cancer risk. Although aspirin has been studied for various cancers, its role in lowering breast cancer risk remains under investigation. In this trial, participants will receive low-dose aspirin to further explore its potential in reducing breast cancer risk by minimizing swelling. ^{2 6 7 8 9}

Who Is on the Research Team?

Kathryn J. Ruddy

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for postpartum women aged 18-45 with benign breast disease who've had a live birth within the last 10 years. They must have hemoglobin levels >=9.0 g/dL, platelet count >=100,000/mm^3, serum creatinine =<2.0 mg/dl, and not be pregnant or planning pregnancy soon. Participants should not be on aspirin/NSAIDs or have any contraindications to aspirin use.

Inclusion Criteria

Provide written informed consent

I have had or will have a biopsy for a breast lesion suspected to be benign.

I am pre-menopausal according to my own report or doctor's assessment.

Exclusion Criteria

Co-morbid illnesses/conditions which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

I have taken aspirin or NSAIDs recently.

I am currently on blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive low-dose aspirin daily and undergo blood collection

6-9 weeks

Regular visits for blood collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low-Dose Aspirin

Trial Overview

The study tests if low-dose aspirin can change inflammation markers in blood/tissue which might prevent breast cancer after childbirth. It involves biospecimen collection, questionnaires, and ultrasound-guided biopsies to monitor effects.

How Is the Trial Designed?

Group I: Prevention (low-dose aspirin) Experimental Treatment 4 Interventions

Patients undergo standard of care breast biopsy for assessment of abnormalities seen on imaging, as well as collection of blood during screening. If cancer is found, patient is taken off study and treatment options are discussed with treating physician. Patients without a cancer finding on biopsy then receive low-dose aspirin by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo breast biopsy as clinically indicated.

Low-Dose Aspirin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Cardiovascular disease prevention
• Colorectal cancer prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Cardiovascular disease prevention
• Colorectal cancer prevention
• Myocardial infarction prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Cardiovascular disease prevention
• Colorectal cancer prevention

Approved in Japan as Aspirin for:

• Pain relief
• Fever reduction
• Cardiovascular disease prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Cardiovascular disease prevention

Approved in Switzerland as Aspirin for:

• Pain relief
• Fever reduction
• Cardiovascular disease prevention
• Colorectal cancer prevention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Recent meta-analyses of randomized-controlled trials have shown that daily aspirin may have beneficial effects on cancer outcomes, prompting a re-evaluation of its role in cancer prevention and treatment.

New evidence from a trial focused on individuals with hereditary cancer predisposition indicates that aspirin can prevent cancer, while observational studies suggest that aspirin use after a cancer diagnosis improves survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence for the use of aspirin in the treatment of cancer. Langley, RE.[2022]

Aspirin and other NSAIDs show promise in preventing colorectal cancer and potentially other cancers, but more research is needed to fully understand their risk-benefit profiles and to make definitive recommendations.

Aspirin is favored for chemoprevention due to its cardiovascular benefits, but studies are required to determine the optimal dosage, treatment duration, and specific populations that would benefit most while minimizing side effects like peptic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement. Cuzick, J., Otto, F., Baron, JA., et al.[2022]

In a study of 21,414 women with stage I-III breast cancer, low-dose aspirin use before or after diagnosis did not show a significant association with breast cancer-specific death or recurrence overall.

However, among women with stage I tumors, there was a notable reduction in breast cancer death associated with aspirin use after diagnosis, suggesting a potential benefit that needs further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No association between low-dose aspirin use and breast cancer outcomes overall: a Swedish population-based study. Frisk, G., Ekberg, S., Lidbrink, E., et al.[2019]

In a study of 1,435 breast cancer patients, post-diagnostic use of low-dose aspirin showed no significant association with reduced breast cancer-specific deaths, with an odds ratio of 0.98, indicating little to no protective effect.

The analysis did not find a dose-response relationship or significant differences based on cancer stage or hormone therapy, suggesting that low-dose aspirin may not be an effective intervention for improving survival in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-diagnostic prescriptions for low-dose aspirin and breast cancer-specific survival: a nested case-control study in a breast cancer cohort from the UK Clinical Practice Research Datalink. Murray, LJ., Cooper, JA., Hughes, CM., et al.[2022]

In a study of 148,739 women with diabetes, low-dose aspirin use was associated with a 27% reduced risk of hormone receptor-positive breast cancer, indicating its potential as a chemopreventive agent for this subtype.

Higher cumulative doses of aspirin (over 8,600 mg) significantly lowered the risk of hormone receptor-positive breast cancer, while doses over 88,900 mg reduced the risk for both hormone receptor-positive and negative breast cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and Risk of Specific Breast Cancer Subtype in Women with Diabetes. Yang, YS., Kornelius, E., Lo, SC., et al.[2023]

In a study of 137 aspirin users, only 9.5% were aware of its potential to reduce colorectal cancer risk, highlighting a significant gap in patient knowledge about the medication's benefits beyond heart disease prevention.

Aspirin compliance was low at 25.6%, with a notable association found between compliance and the presence of diabetes mellitus, suggesting that certain health conditions may influence adherence to aspirin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin Use, Compliance, and Knowledge of Anticancer Effect in the Community. Ranger, GS., McKinley-Brown, C., Rogerson, E., et al.[2022]

In a study of 1227 patients with BRCA, those who used high-dose aspirin (325 mg) showed significantly better survival outcomes compared to those using low-dose aspirin (81 mg), suggesting a potential benefit of higher doses in treatment.

Patients who started using aspirin after their diagnosis experienced even greater survival benefits, indicating that aspirin may play a role in improving treatment outcomes for BRCA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin Treatment Effect and Association with PIK3CA Mutation in Breast Cancer: A Biomarker Analysis. Zhou, Y., Simmons, J., Jordan, CD., et al.[2020]

In a long-term study involving low-dose aspirin (100 mg every other day) over an average of 10 years, there was no overall effect on the prevention of invasive breast cancer.

Subgroup analyses indicated that low-dose aspirin did not show any preventive effects based on different tumor characteristics at diagnosis, reinforcing the conclusion that it is not effective for breast cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose aspirin and breast cancer risk: results by tumour characteristics from a randomised trial. Zhang, SM., Cook, NR., Manson, JE., et al.[2021]

Regular aspirin use has been associated with improved breast cancer survival rates, as indicated by multiple observational studies and pooled data from five large randomized trials involving cardiovascular disease.

The review suggests that aspirin may reduce cancer mortality and the risk of metastatic cancer, although the exact mechanisms are still unclear and could involve factors like inflammation and hormonal pathways, warranting further phase III randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Aspirin in Breast Cancer Survival. Chen, WY., Holmes, MD.[2018]

Regular use of low-dose aspirin (three or more tablets per week) is associated with a 16% reduced risk of developing invasive breast cancer, particularly in women with the hormone receptor-positive/HER2-negative subtype, based on a study of 57,164 female public school professionals in California.

This study is the first to indicate that the risk reduction is specific to low-dose aspirin rather than regular-dose aspirin, highlighting the need for further research into low-dose aspirin as a potential preventive measure against breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regular and low-dose aspirin, other non-steroidal anti-inflammatory medications and prospective risk of HER2-defined breast cancer: the California Teachers Study. Clarke, CA., Canchola, AJ., Moy, LM., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

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Among low-dose aspirin users, the cumulative incidence of breast cancer recurrence from 1 year after diagnosis was 10.7%, 13.2%, 17.0% and 17.8% ...

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sciencedirect.com

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Low-dose acetylsalicylic acid for cancer prevention ...

Conclusions. Our results suggest that aspirin intake is associated with a reduced incidence of colorectal, pancreatic, and prostate cancers and lymphomas.

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nature.com

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Regular aspirin use, breast tumor characteristics and long- ...

During up to 34 years of follow-up, regular post-diagnostic aspirin use was associated with a 38% and 28% lower risk of breast cancer-specific and total ...

4.

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Low-dose acetylsalicylic acid reduces local inflammation ...

We investigated whether low-dose acetylsalicylic acid (ASA) affects local breast tissue inflammation and/or structural and dynamic changes in dense breasts.

5.

academic.oup.com

academic.oup.com/oncolo/article/29/1/e1/7207782

Aspirin Use and Survival Among Patients With Breast Cancer

The only significant association of aspirin with breast cancer outcomes is lower breast-cancer-specific mortality in patients who used aspirin ...

6.

nature.com

nature.com/articles/s41416-025-03112-3

Association between low-dose aspirin use and breast ...

Among low-dose aspirin users, the cumulative incidence of breast cancer recurrence from 1 year after diagnosis was 10.7%, 13.2%, 17.0% and 17.8% ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4269341/

Estimates of benefits and harms of prophylactic use ...

Our analyses show that prophylactic aspirin use for a minimum of 5 years at doses between 75 and 325 mg/day appears to have favourable benefit–harm profile.

8.

cancerchoices.org

cancerchoices.org/therapy/aspirin/safety/

Aspirin: Safety and precautions

Safety and precautions · Higher risk of sudden death among people using aspirin with low body weight for the dose received · 52% higher all-cause ...

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cancer.org

cancer.org/cancer/latest-news/can-aspirin-help-reduce-your-cancer-risk.html

Can Aspirin Help Reduce Your Cancer Risk?

Researchers found that the people taking a daily low dose of aspirin were 55% less likely to have their cancer come back than those who did not take daily ...