Clinical trial Recruiting at 4 sites Phase 2 Interventional Ages 18 to 45 Women only

Using low-dose aspirin to prevent postpartum breast cancer

Official title: Targeted Prevention of Postpartum-Related Breast Cancer

Run by Mayo Clinic · NCT05557877 · Data updated 2026-11-12

This study is testing if taking low-dose aspirin can help lower the risk of breast cancer in new mothers who are about to have a breast biopsy.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 45 Years
SexWomen only
Enrollment60 (estimated)
SponsorMayo Clinic
Academic / other
Locations5 sites (Scottsdale, Arizona and 4 other locations)
StatusRecruiting
StartedMarch 9, 2023
Main results expectedJuly 30, 2027
Study endsJuly 30, 2027
Registry record updatedOctober 1, 2026
Trial IDNCT05557877 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are postpartum women aged 18 to 45 who have had a live birth within the last 10 years and are pre-menopausal.

Probably not a fit

Patients who are older than 45 or who have a history of breast cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effects of low-dose aspirin on inflammation markers in postpartum women who are planning to undergo a breast biopsy. The study aims to determine if aspirin can reduce the risk of postpartum-related breast cancer by evaluating changes in specific cancer-related scores and inflammatory markers before and after treatment. Participants will receive daily low-dose aspirin and undergo blood and tissue collection for analysis. If cancer is detected during the biopsy, participants will be removed from the study and provided with treatment options.

Why it matters

Potential benefit: If successful, this approach could reduce the incidence of postpartum-related breast cancer in women.

How similar studies have gone: While the use of low-dose aspirin for cancer prevention is being explored, this specific approach targeting postpartum-related breast cancer is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Mayo Clinic in Florida
    Jacksonville, Florida, United States
    Recruiting
  • Indiana University Simon Comprehensive Cancer Center
    Indianapolis, Indiana, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting
  • University of North Carolina
    Chapel Hill, North Carolina, United States
    Recruiting
  • Mayo Clinic in Arizona
    Scottsdale, Arizona, United States
    Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.