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

Submitted by aschwalb on Thu, 08/10/2017 - 14:05
Study ID
DFCI 16-727
Trial Conditions New
Study Information

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. Aspirin or placebo will be taken daily for 5 years. People who were recommended hormonal therapy will continue their hormonal therapy as directed.

• Visit www.abctrial.org for more information. • Contact Wendy Loeser, RN with any questions you may have.

Physician
Contact Information

Wendy Loeser RN OCN Clinical Research Dana-Farber Cancer Institute at St. Elizabeth's Medical Center 736 Cambridge St Boston, MA 02135 617-789-3385 Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
The purpose of this study is to determine if aspirin can prevent a recurrence of breast cancer or prevent the spread of breast cancer (metastatic breast cancer). Recent studies around the world have linked aspirin with a lower risk of death from cancer. This ABC Trial is the first U.S. study to test whether aspirin will keep breast cancer from recurring and reduce death from breast cancer.
Phase
3
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Eligibility

• Women or men with node positive, HER2 negative, stage II or III breast carcinoma within one year of diagnosis and free of recurrence. •If any chemotherapy and/or endocrine therapy the last dose 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. •Age > 18 and < 70 years of age. •Platelet count ≥ 100,000/mm3 Exclusions: •No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention. • No history of any prior stroke • No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors. • No history of atrial fibrillation or myocardial infarction. • No history of grade 4 hypertension. •No chronic (duration >30 days) daily use of oral steriods. • No known allergy to aspirin. • No other cancer 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. • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.