Study to determine if aspirin prevents breast cancer recurrence

Study ID: A011502

Aspirin in preventing recurrence of cancer in patients with node-positive, HER2-negative stage 2–3 breast cancer after chemotherapy, surgery and/or radiation therapy

This study seeks to determine if taking aspirin once daily for five years will prevent recurrence of a certain type of breast cancer. Participants receive either aspirin or a placebo orally once daily for five years as long as the disease does not progress and there is no toxicity.

Inclusion criteria:

  • Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma within one year of diagnosis and free of recurrence. 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.
  • Any ER/PgR status allowed.
  • Prior adjuvant treatment with chemotherapy and/or endocrine therapy allowed. Last dose of chemo or radiation must be at least 60 days prior to study registration. Concurrent hormonal therapy allowed.
  • Regular NSAID/aspirin use (defined as ≥ 5 days per week) allowed if stopped for one year prior to study entry and throughout the study period. Subjects will be encouraged to use acetaminophen for minor pain and fever.
  • Patients must be enrolled within 1 year after diagnosis.
  • History of gastric/duodenal ulcers documented on endoscopy eligible as long no bleeding occurred requiring blood transfusion/major intervention.
  • Helicobacter pylori positive patients must have completed a course of H.pylori eradication treatment.
  • No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention, prior stroke (hemorrhagic or ischemic), concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors, atrial fibrillation or myocardial infarction, or grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis).
  • No chronic (>30 days) daily use of oral steroids.
  • No known allergy to aspirin.
  • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.

Inclusion Snapshot

  • Must have been diagnosed with node-positive, HER2-negative stage 2-3 breast cancer within the past year and completed chemotherapy, surgery and/or radiation therapy, if applicable
  • Must be able to use acetaminophen, rather than aspirin, for minor pain relief and fever during the trial
  • Must not be allergic to aspirin

Contact Information

Lankenau Institute for Medical Research trial