Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Recruiting now · Phase 2

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT05557877

Run by

Mayo Clinic

People needed

60

Starts

2023-03-09

Expected to finish

2027-01-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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