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Aspirin may shield new moms from breast cancer

NCT ID NCT05557877

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests whether taking low-dose aspirin can lower inflammation and reduce the risk of breast cancer in women who have had a baby within the last 10 years. About 60 women planning a breast biopsy will take aspirin and have blood and tissue samples checked for changes. The goal is to see if a simple, low-cost pill could help prevent postpartum-related breast cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Indiana University Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic in Arizona

    TERMINATED

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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