Actively Recruiting
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
Led by Mayo Clinic · Updated on 2026-05-12
60
Participants Needed
5
Research Sites
203 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 45 years
- Willing to provide tissue specimens for research at two timepoints
- Had a live birth within 10 years prior to enrollment
- Pre-menopausal by patient report or clinical determination
- Provide written informed consent
- Able to complete questionnaires independently or with help
- Willing to provide blood and urine samples for research
- Registration completed within 1 year after qualifying biopsy or archived tissue collection
- Hemoglobin 9.0 g/dL or higher (within 90 days prior to registration)
- Platelet count 100,000/mm^3 or higher (within 90 days prior to registration)
- Serum creatinine 2.0 mg/dl or lower (within 90 days prior to registration)
- Negative pregnancy test within 15 days prior to registration
- Willing to use contraception during treatment
- Willing to return for follow-up visits during active monitoring phase
You will not qualify if you...
- History of breast cancer including ductal carcinoma in situ (DCIS)
- Prior systemic treatment for any cancer
- Current use of aspirin or NSAIDs (within 5 days prior or more than four doses in last 30 days)
- Current use of other breast cancer prevention agents
- Current use of anticoagulants
- Contraindications to aspirin use
- Known or suspected active breast infection
- Known DCIS or invasive cancer at registration
- No research tissue available from recent biopsy or archived tissue
- Co-morbid conditions interfering with study safety or assessments
- Bleeding disorders or stomach/intestine bleeding within 6 months
- Known allergy to NSAIDs
- Any prior or current malignancy requiring systemic therapy
- Currently pregnant or planning pregnancy within 90 days
- Post-menopausal status including bilateral oophorectomy or no menses for over 1 year with hormone levels in postmenopausal range
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Terminated
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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