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Trial Summary

Protocol No.A011502
StatusOPEN TO ACCRUAL
Principal InvestigatorMiller, Kathy
ScopeNational
PhasePhase III
Age GroupAdult
TitleA RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR NODE POSTIVE HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL
DescriptionThis 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • 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.
  • Disease status - Any ER/PgR status allowed.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast Cancer
Participating InstitutionsIndiana University (IU)
  • Eskenazi Hospital
  • IU Health Methodist Hospital
  • IU Health North (For use by Cancer Center CTO only)
  • IU Health West (For use by Cancer Center CTO only)
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactMary Collins, Phone:
Pager: 317-312-1836
Email: marlcoll@iupui.edu