Low-Dose Aspirin for Breast Cancer Prevention
What You Need to Know Before You Apply
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 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.12345
Is low-dose aspirin a promising drug for preventing breast cancer?
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.347910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low-dose aspirin daily and undergo blood collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low-Dose Aspirin
Low-Dose Aspirin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Pain relief
- Fever reduction
- Cardiovascular disease prevention
- Colorectal cancer prevention
- Pain relief
- Fever reduction
- Cardiovascular disease prevention
- Colorectal cancer prevention
- Myocardial infarction prevention
- Pain relief
- Fever reduction
- Cardiovascular disease prevention
- Colorectal cancer prevention
- Pain relief
- Fever reduction
- Cardiovascular disease prevention
- Pain relief
- Fever reduction
- Cardiovascular disease prevention
- Pain relief
- Fever reduction
- Cardiovascular disease prevention
- Colorectal cancer prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator