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

K
Kathy Miller, MD

Primary Investigator

Overview

This 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.

Description

The purpose of this study is to compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    breast cancer
  • Age: Between 18 Years - 69 Years
  • Gender: All

Inclusion Criteria
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
Any ER/PgR status allowed
Prior adjuvant treatment with chemotherapy and/or endocrine 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. Concurrent hormonal therapy will be allowed
Regular NSAID/aspirin use (defined as ? 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. Participants will be encouraged to use acetaminophen for minor pain and fever
Patients must be enrolled within 1 year after diagnosis
ECOG performance status 0-2
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention
For patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed
Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use
Exclusion Criteria
History of GI bleeding requiring a blood transfusion, endoscopic or operative intervention
History of any prior stroke (hemorrhagic or ischemic)
Concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors
History of atrial fibrillation or myocardial infarction
History of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis)
Chronic (duration >30 days) daily use of oral steroids
Known allergy to aspirin
Prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1701922942 (A011502)

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center