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Protocol No. A011502

Principal Investigator Tevaarwerk, Amye

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin As Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

Objective 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.

Treatment 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.

Description This study has two study groups. Group 1 will receive the study drug, aspirin at 300 mg per day, which is a dose that is available over the counter without a prescription. Group 2 will receive a placebo, a pill that looks like the study drug, but contains no medication. People who were recommended hormonal therapy will continue their hormonal therapy as directed. A computer will by chance assign you to one of the treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. Neither you nor your doctor can choose the group that you will be in. You will have a 50% chance of being placed in the group receiving aspirin. Neither you nor your doctor will know which group you are assigned to.

Key Eligibility
  • Patients (women and men) must be node positive, HER2 negative, stage II or III breast carcinoma within one year of diagnosis and free of recurrence
  • Patients must be enrolled within 1 year after diagnosis.
  • Any ER or PR status is allowed.
  • Patients must be between 18 and 70 years of age.
  • Prior treatment with chemotherapy and/or hormone 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. Patients can continue to take hormonal therapy.

Applicable Disease Sites Breast

Status Open

Participating Institutions Bellin Memorial Hospital/Cancer Team at Bellin Health; Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park