Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
Condition: Node Positive HER2 Negative Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Placebo; Aspirin
Intervention description: Given PO; Given PO
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3021.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well aspirin works in preventing the cancer from
      coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2)
      negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a
      drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in
      cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with
      breast cancer.
    

Eligibility criteria:

        -  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