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Aspirin in Preventing Recurrence of Cancer in Patients With Node Positive Triple Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

Status: Recruiting
Phase: Phase 3
Diagnosis: Lung Cancer, Breast: Early Stage Disease
NCT ID: NCT02927249 (View complete trial on
DFCI Protocol ID: 16-727


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) 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.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Wendy Chen, MD, MPH, Dana Farber Cancer Institute

Site-responsible Investigators:
Neelam Desai, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Bryan Marion,
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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. 19. Required Initial Laboratory Values Platelet count ≥ 100,000/mm3
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