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

Trial Summary

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.

What data supports the idea that Low-Dose Aspirin for Breast Cancer Prevention is an effective drug?

The available research shows mixed results about the effectiveness of low-dose aspirin for breast cancer prevention. One study found that low-dose aspirin did not prevent breast cancer overall. However, another study found that in women with diabetes, low-dose aspirin reduced the risk of a specific type of breast cancer by 31% when taken in higher cumulative doses. Additionally, some observational studies suggest that regular aspirin use may improve breast cancer survival, although more research is needed to confirm these findings. ^{1 2 3 4 5}

What safety data exists for low-dose aspirin in breast cancer prevention?

The safety data for low-dose aspirin in breast cancer prevention is mixed. Some studies suggest a potential chemopreventive effect, particularly for hormone receptor-positive breast cancer, but others, like the Women's Health Study, found no overall preventive effect. Aspirin is known for its cardiovascular benefits, but its main side effect is peptic ulcers, which can be mitigated by coadministration with a proton-pump inhibitor. Concerns about toxicity, especially major hemorrhage, have limited its use in primary prevention. More research is needed to determine the optimal dose, treatment duration, and target populations. ^{2 3 6 7 8}

Is low-dose aspirin a promising drug for preventing breast cancer?

Low-dose aspirin does not seem to prevent breast cancer in general. However, it might help reduce the risk of certain types of breast cancer in women with diabetes, especially those with hormone receptor-positive tumors. More research is needed to confirm these findings. ^{1 2 3 9 10}

What is the purpose of this trial?

This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) women planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.

Research Team

Kathryn J. Ruddy

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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 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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Low-dose aspirin and breast cancer risk: results by tumour characteristics from a randomised trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Aspirin and Risk of Specific Breast Cancer Subtype in Women with Diabetes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Role of Aspirin in Breast Cancer Survival. [2018]

5. England pubmed.ncbi.nlm.nih.gov

No association between low-dose aspirin use and breast cancer outcomes overall: a Swedish population-based study. [2019]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Aspirin Treatment Effect and Association with PIK3CA Mutation in Breast Cancer: A Biomarker Analysis. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Aspirin Use, Compliance, and Knowledge of Anticancer Effect in the Community. [2022]