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Alliance A011502 for HER2 Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if using aspirin after completing the usual chemotherapy, surgery, and/or radiation therapy for breast cancer will lower the rate of the cancer returning.

What is the Condition Being Studied?

HER2 Negative Breast Cancer

Who Can Participate in the Study?

Adults greater than 18 years of age but less than 70 years of age with HER2 negative breast cancer who do not have:
- A history of gastric or duodenal ulcers
- Gastrointestinal bleeding that required a blood transfusion or surgery
- A history of stroke
- To take blood thinners such as warfarin, heparin, clopidogrel or others
- A history of atrial fibrillation or heart attack
- Allergy to aspirin
- A history of metastatic breast cancer
- Uncontrolled hypertension

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be assigned to one of two study groups (like the flip of a coin):
-- One group will get aspirin and the other group will get a placebo (a pill that looks like the study drug but contains no medicine)
- Take the study drug (aspirin or placebo) every day for not more than 5 years
- See your study doctor every 6 months to talk about any side effects you may be having while taking the study drug
- Be given a medication log to record the date, time, and number of pills taken each day and list any side effects you may be having

Study Details

Full Title
Alliance A011502: A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00078530
NCT:NCT02927249
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698