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A011502 A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy for HER2 negative breast cancer (The ABC Trial)
Protocol Number:
Phase III
Kala Visvanathan
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Suburban Hospital
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.
Generally healthy adults with a history of node positive breast cancer may be eligible to participate.
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. 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.You will take one (1) aspirin or placebo tablet every day with food, or a full glass of water to help lessen stomach upset. The tablets should NOT be crushed.If you choose to take part in the study, you will need to meet with your study doctor every six months to review any side effects and also to see if you are taking the study drug as directed.You will receive the study drugs for a maximum of 5 years. After you finish the study drugs, your doctor will continue to watch you for side effects and follow your condition for another 5 years.
Last Update
08/08/2020 05:02 AM