Low-Dose Aspirin for Postpartum Breast Cancer Prevention
This study is testing if low-dose aspirin can help prevent postpartum-related breast cancer in women aged 18 to 45 who have had a live birth within the last 10 years and are pre-menopausal. Researchers believe that chronic inflammation after childbirth might increase the risk of this type of cancer, and low-dose aspirin, an anti-inflammatory medicine, might reduce this risk. You would receive low-dose aspirin daily and have blood and tissue samples collected. The main goal is to see how low-dose aspirin changes a score related to postpartum breast cancer. This study plans to enroll 60 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment (low-dose aspirin). It plans to enroll 60 women.
- What's involved
- You would undergo blood collection and a breast biopsy (if clinically indicated) at the start. If no cancer is found, you would then take low-dose aspirin daily and have more blood collected. You may also have another breast biopsy if needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed up for up to 30 days after completing the study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05557877
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
Recruiting
PHASE2Ages 18–45InterventionalPreventionMayo ClinicInvestigator-initiated
~60 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionLow-Dose AspirinQuestionnaire AdministrationBiopsy
At a glance
Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pregnancy-related breast cancer (PRBC) score
Measured over Up to 30 days
Conditions
Where it's being run
5 sites across 5 statesArizona1
Florida1
Indiana1
Minnesota1
North Carolina1
Study leadership
- Kathryn J. Ruddy, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PRE-REGISTRATION: Age \>= 18 years and =\< 45 years of age
PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints.
PRE-REGISTRATION: Had a live birth =\< 10 years prior to pre-registration
PRE-REGISTRATION: Pre-menopausal according to patient report and/or clinical determination
PRE-REGISTRATION: Provide written informed consent
PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
REGISTRATION: Age \>= 18 years and =\< 45 years of age
REGISTRATION: Registration for this study must be completed either =\< one (1) year after the qualifying pre-registration biopsy is performed for this study or =\< one (1) year after collection of the archived tissue (for those who did not have a pre-registration biopsy performed after pre-registration for this study)
REGISTRATION: Hemoglobin \>= 9.0 g/dL (obtained =\< 90 days prior to registration)
REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 90 days prior to registration
REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< 90 days prior to registration)
REGISTRATION: Negative pregnancy test done =\< 15 days prior to registration
REGISTRATION: Willing to use contraception while on treatment
REGISTRATION: Provide written informed consent
REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion
PRE-REGISTRATION: History of breast cancer including ductal breast carcinoma in situ (DCIS)
PRE-REGISTRATION: Received systemic treatment for any other cancer at any time
PRE-REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within =\< 5 days prior to pre-registration and no more than four doses within =\< 30 days prior to pre-registration)
PRE-REGISTRATION: Currently taking other agents for the prevention of breast cancer
PRE-REGISTRATION: Currently taking anticoagulants
PRE-REGISTRATION: Contraindication for aspirin use
PRE-REGISTRATION: Known or suspected active breast infection
REGISTRATION: Known DCIS or invasive cancer
REGISTRATION: No research tissue available from pre-registration biopsy or from archived tissue (collected =\< 12 months prior to pre-registration)
REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) (NOTE: no doses within =\< 5 days prior to registration and no more than four doses within =\< 30 days prior to registration)
REGISTRATION: 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
REGISTRATION: Any contraindication to aspirin use including but not limited to:
Bleeding disorders (e.g., hemophilia)
Stomach or intestinal bleeding =\< 6 months prior to registration
Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs)
REGISTRATION: Currently taking anticoagulants
REGISTRATION: Any prior or current malignancy requiring prior or current systemic therapy
REGISTRATION: Currently pregnant or planning to become pregnant in the next 90 days
REGISTRATION: Post-menopausal:
Prior bilateral surgical oophorectomy or
No menses for \> 1 year with estradiol levels within postmenopausal range, according to institutional standard
REGISTRATION: Known or suspected active breast infection
What this trial measures
- Change in pregnancy-related breast cancer (PRBC) scoreUp to 30 days
Assessed using pre- versus post-treatment PRBC scores. Patients who are eligible, consented, received at least 70% of the study treatment, and provided both a pre- and post-intervention tissue specimen will be evaluated for this outcome.