Aspirin may shield new moms from breast cancer
NCT ID NCT05557877
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Indiana University Simon Comprehensive Cancer Center
RECRUITINGIndianapolis, Indiana, 46202, United States
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Mayo Clinic in Arizona
TERMINATEDScottsdale, Arizona, 85259, United States
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224-9980, United States
Contact Email: •••••@•••••
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
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Other studies related to the condition(s) this trial covers.
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