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A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin As
Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial
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 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.
- 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
Bellin Memorial Hospital/Cancer Team at Bellin Health; Dean Health System, Hematology and Oncology Clinic ; Johnson Creek, UW Cancer Center; Mercy Health Systems, Janesville ; UW Hospital and Clinics; UWCCC 1 South Park