RecruitingPhase 2NCT05557877

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Targeted Prevention of Postpartum-Related Breast Cancer

Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Carcinoma

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria18

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 =\< 30 days prior to registration)
REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 30 days prior to registration
REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< days prior to registration)
REGISTRATION: Negative pregnancy test done =\< 14 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: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria22

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