Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Inclusion Criteria:

• PRE-REGISTRATION: Age >= 18 years and =< 45 years of age

• PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlativeresearch 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 clinicaldetermination

• PRE-REGISTRATION: Provide written informed consent

• PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or withassistance

• PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens forcorrelative research

• REGISTRATION: Age >= 18 years and =< 45 years of age

• REGISTRATION: Registration for this study must be completed either =< one (1) yearafter 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 apre-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 toregistration

• 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 forcorrelative research

• REGISTRATION: Willing to return to enrolling institution for follow-up (during theactive 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-inflammatorydrugs (NSAIDS) (no doses within =< 5 days prior to pre-registration and no more thanfour 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 fromarchived tissue (collected =< 12 months prior to pre-registration)

• REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatorydrugs (NSAIDs) (NOTE: no doses within =< 5 days prior to registration and no morethan four doses within =< 30 days prior to registration)

• REGISTRATION: Co-morbid illnesses/conditions which, in the judgment of theinvestigator, would make the patient inappropriate for entry into this study orinterfere significantly with the proper assessment of safety and toxicity of theprescribed 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 systemictherapy

• 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