Eligibility Details:
- Histologic documentation of women or men with node positive, HER2 negative, anatomic
stage II or III breast carcinoma and high risk node negative (defined as estrogen
receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within
one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if
neoadjuvant therapy was received, either initial clinical stage (determined by
physical and or radiologic examination) or post-operative pathologic stage can be used
for eligibility purposes, with the higher stage determining eligibility; histologic
documentation of node positivity is required; bilateral breast cancers are allowed, as
long as both cancers are HER2 negative and at least one of the cancers meets
eligibility
- Any ER/progesterone receptor (PgR) status allowed
- Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by
the treating physician, is allowed; the last dose of chemotherapy or radiation therapy
must be at least 30 days prior to study registration; concurrent hormonal therapy will
be allowed
- Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including
baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are
stopped for 30 days prior to study entry and throughout the study period; participants
will be encouraged to use acetaminophen for minor pain and fever
- Patients must be enrolled within 1 year after diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can
be enrolled as long as the ulcers did not cause bleeding requiring a blood
transfusion/major intervention; for patients who are Helicobacter pylori positive, a
course of Helicobacter pylori eradication treatment must have been completed
- No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion,
endoscopic or operative intervention
- No history of any prior stroke (hemorrhagic or ischemic)
- No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel,
oral direct thrombin inhibitors, or direct factor XA inhibitors
- No history of atrial fibrillation or myocardial infarction
- No history of grade 4 hypertension, defined as hypertension resulting in
life-threatening consequences (e.g., malignant hypertension, transient or permanent
neurologic deficit, hypertensive crisis)
- No chronic (duration > 30 days) daily use of oral steroids
- No known allergy to aspirin
- No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS])
within the past 5 years except for current diagnosis of breast cancer, and any prior
diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the
cervix; patients with a prior history of breast cancer greater than 5 years from study
screening may participate in this study
- Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long
as that trial allows concurrent daily aspirin use
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
