Low-Dose Aspirin for Breast Cancer Prevention
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Must not be taking: NSAIDs, Anticoagulants
Disqualifiers: Breast cancer, Other cancer, Post-menopausal, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
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.
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.12345
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.23678
Is low-dose aspirin a promising drug for preventing 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 am between 18 and 45 years old.
I have had or will have a biopsy for a breast lesion suspected to be benign.
See 9 more
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.
See 11 more
Trial 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 (Non-Steroidal Anti-Inflammatory Drug)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Prevention (low-dose aspirin)Experimental Treatment4 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
Indiana University Simon Comprehensive Cancer CenterIndianapolis, IN
Mayo Clinic in ArizonaScottsdale, AZ
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Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3427
Patients Recruited
3,221,000+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+
References
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]Recent observational studies indicate that post-diagnostic use of aspirin in breast cancer patients may protect against cancer progression perhaps by inhibiting cyclooxygenase-2 dependent mechanisms. Evidence also supports a crucial role for interactions between tumour cells and circulating platelets in cancer growth and dissemination, therefore, use of low-dose aspirin may reduce the risk of death from cancer in breast cancer patients.
Low-dose aspirin and breast cancer risk: results by tumour characteristics from a randomised trial. [2021]The Women's Health Study trial previously reported no overall effect of low-dose aspirin (100 mg every other day) on invasive breast cancer over an average of 10 years of treatment. The present subgroup analyses further show no effects by tumour characteristics at diagnosis, suggesting that low-dose aspirin has no preventive effect on breast cancer.
Aspirin and Risk of Specific Breast Cancer Subtype in Women with Diabetes. [2023]Purpose: Low-dose aspirin was associated with a reduced risk of breast cancer in women with diabetes. However, whether the protective effect of aspirin varies as a function of the hormone receptor status of breast cancer remained an unanswered question. This study aims to explore the association between aspirin use and the risk of specific breast cancer subtypes in women with diabetes. Methods: Population-based retrospective cohort study of women with diabetes, using the Taiwan National Health Insurance reimbursement database (year 1998 to 2011). Patients diagnosed to have diabetes with new low-dose aspirin use (75-165 mg per day) for at least 28 days of prescription were identified as the study population, while patients without low-dose aspirin use were selected as controls. The main outcome measure was breast cancer by aspirin use and hormone receptor status. Results: We studied a total of 148,739 patients with diabetes. Their mean (standard deviation) age was 63.3 (12.8) years. During follow-up, a total of 849 breast cancers occurred, including 329 hormone receptor-positive and 529 hormone receptor-negative tumors. A total of 27,378 patients were taking aspirin. The reduction in risk with aspirin use was seen among those with hormone receptor-positive breast cancer (Hazard ratio [HR]: 0.73; 95% confidence interval [CI]: 0.59-0.91) but not for women with hormone receptor-negative breast cancer (HR: 0.88; 95% CI: 0.74-1.05). A cumulative dose of aspirin use of more than 8,600 mg was found to reduce the risk of hormone receptor-positive breast cancer by 31% (HR: 0.69; 95% CI: 0.50-0.97). A cumulative dose of aspirin use of more than 88,900 mg was found to reduce both the risk of hormone receptor-positive and negative breast cancer. Conclusion: These data add to the growing evidence that supports the use of low-dose aspirin as a potential chemopreventive agent for specific subtypes of breast cancer. Further studies are necessary to confirm these findings.
Role of Aspirin in Breast Cancer Survival. [2018]Chemotherapy and hormonal therapy have significantly decreased breast cancer mortality, although with considerable side effects and financial costs. In the USA, over three million women are living after a breast cancer diagnosis and are eager for new treatments that are low in toxicity and cost. Multiple observational studies have reported improved breast cancer survival with regular aspirin use. Furthermore, pooled data from five large randomized trials of aspirin for cardiovascular disease showed that subjects on aspirin had decreased risk of cancer mortality and decreased risk of metastatic cancer. Although the potential mechanism for aspirin preventing breast cancer is not known, possible pathways may involve platelets, inflammation, cyclooxygenase (COX) 2, hormones, or PI3 kinase. This review article summarizes the current epidemiologic and clinical trial evidence as well as possible underlying mechanisms that justify current phase III randomized trials of aspirin to improve breast cancer survival.
No association between low-dose aspirin use and breast cancer outcomes overall: a Swedish population-based study. [2019]Results from previous studies indicate that use of low-dose aspirin may improve breast cancer prognosis. We evaluated aspirin use and breast cancer outcomes in relation to clinical characteristics as well as dose and duration of aspirin use.
Regular and low-dose aspirin, other non-steroidal anti-inflammatory medications and prospective risk of HER2-defined breast cancer: the California Teachers Study. [2023]Regular users of aspirin may have reduced risk of breast cancer. Few studies have addressed whether risk reduction pertains to specific breast cancer subtypes defined jointly by hormone receptor (estrogen and progesterone receptor) and human epidermal growth factor receptor 2 (HER2) expression. This study assessed the prospective risk of breast cancer (overall and by subtype) according to use of aspirin and other non-steroidal anti-inflammatory medications (NSAIDs) in a cohort of female public school professionals in California.
Clinical evidence for the use of aspirin in the treatment of cancer. [2022]Although the anti-cancer effects of aspirin were first identified in pre-clinical models four decades ago, a clear role for the drug in either the prevention or treatment of cancer has not been established. Concerns about toxicity, particularly major haemorrhage, and a lack of randomised evidence demonstrating efficacy have limited its use in primary prevention; there was also doubt that a simple aspirin could have a significant therapeutic effect against established malignancy. Three new pieces of evidence: a series of meta-analyses focusing on cancer outcomes from randomised-controlled trials designed to assess the vascular benefits of daily aspirin; the first positive results from a randomised-controlled trial designed to demonstrate that aspirin can prevent cancer in those with a hereditary predisposition; and observational data showing that aspirin use after a cancer diagnosis improves both cancer mortality and overall survival; have led to a re-evaluation of aspirin as a potential anti-cancer agent both for the prevention and treatment of cancer.
Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement. [2022]Evidence clearly shows a chemopreventive effect for aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) on colorectal cancer and probably other cancer types; however, data on the risk-benefit profile for cancer prevention are insufficient and no definitive recommendations can be made. Aspirin has emerged as the most likely NSAID for use in chemoprevention because of its known cardiovascular benefit and available safety and efficacy data. Other traditional NSAIDs, particularly sulindac, and selective COX-2 inhibitors are now given to patients at high risk of colorectal cancer, although these drugs do not provide cardioprotection. More studies of aspirin and cancer prevention are needed to define the lowest effective dose, the age at which to initiate therapy, the optimum treatment duration, and the subpopulations for which the benefits of chemoprevention outweigh the risks of adverse side-effects. Although it might be possible to answer some of these questions with longer follow-up of existing clinical trials, randomised controlled trials with new study designs will be needed. Future projects should investigate the effects of aspirin treatment on multiple organ systems. Cancers of interest are colorectal, breast, prostate, lung, stomach, and oesophageal. The main side-effect of aspirin is peptic ulcers; therefore coadministration of aspirin with a proton-pump inhibitor is an attractive option and is under investigation in the AspECT trial.
Aspirin Treatment Effect and Association with PIK3CA Mutation in Breast Cancer: A Biomarker Analysis. [2020]Studies suggest regular aspirin use decreases breast cancer (BRCA) risk, with high doses exerting an "anti-cancer" effect. Despite reports suggesting aspirin's protective role in BRCA, no findings on aspirin dose association(s) with treatment outcomes have been reported, nor have any molecular subtype associations by which aspirin influences outcomes been elucidated. To interrogate aspirin's effect and determine which populations may benefit from its use, we retrospectively explored data from 1227 patients with BRCA. In this population, 32 used high-dose aspirin (325 mg), 121 used low-dose aspirin (81 mg), and 1074 used no aspirin before and/or after diagnosis.
Aspirin Use, Compliance, and Knowledge of Anticancer Effect in the Community. [2022]Millions of adults worldwide use low-dose aspirin for secondary prevention of heart disease. Results of randomized trials indicate that regular use of low-dose aspirin may reduce the risk of colorectal cancer by more than 20%, leading to speculation of its chemoprevention role for high-risk groups. Little is known, however, about the use of aspirin in our community.