"Effects of using aspirin after completing the usual chemotherapy, surgery and/or radiation therapy for breast cancer"
18 to 69 years old
Other study, Phase 3
The purpose of this study is to compare any good and bad effects of using aspirin after someone has completed the usual chemotherapy, surgery and/or radiation therapy for breast cancer. Some studies have suggested that aspirin may lower the risk of breast cancer coming back, but others have not, so we do not know if aspirin will help decrease breast cancer recurrence. This study will evaluate whether patients taking aspirin once per day will have a lower rate of cancer recurrence than patients taking a placebo. A placebo is a tablet that looks like the study drug (aspirin), but contains no medication. Aspirin is approved by the Federal Drug Administration (FDA) of the United States, but is not approved for the purpose of lowering the risk of breast cancer coming back or improving survival.
This study requires
Blood samples Urine samples Sample of cancer tissue from surgery Aspirin or placebo daily
Who can participate?
1. Documentation of Disease - Histologic Documentation: 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. Histologic documentation of node positivity is required.
2. Disease status - Any ER/PgR status allowed.
3. Prior Treatment - Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined the treating physician, is allowed. The last dose of chemotherapy or radiation therapy must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed.
4. Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. Participants will be encouraged to use acetaminophen for minor pain and fever.
5. Patients must be enrolled within 1 year after diagnosis.
6. Age > 18 and < 70 years of age.
7. ECOG performance status 0-2.
8. 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.
9. For patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed.
10. No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
11. No history of any prior stroke (hemorrhagic or ischemic).
12. No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors.
13. No history of atrial fibrillation or myocardial infarction.
14. 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).
15. No chronic (duration >30 days) daily use of oral steroids.
16. No known allergy to aspirin.
17. No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
18. Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.