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A011502: Aspirin in Preventing Recurrence of Cancer in Patients With Node Positive HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

Clinical Trial Details

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. 

As part of this study you will be asked to complete five brief questionnaires, before starting the study drug, and after two years of taking the study drug. The information from these questionnaires will be used for future studies to evaluate any lifestyle factors that may be related to inflammation. It will take about 15-30 minutes to complete all of the questionnaires. 

There will be about 2936 women and men taking part in this study. 

Key Eligibility: 
  • Open to men or women 18 - 70 years old diagnosed within the last year with node positive, HER2 negative, anatomic stage 2 or 3 breast carcinoma and who have not had a recurrence
  • Prior adjuvant treatment is allowed as determined by the treating physician 
  • Concurrent hormonal therapy is allowed 
  • NSAID/aspirin use must be stopped for a year prior to beginning the study and throughout participation on the study 
  • Patients with a prior history of gastric/duodenal ulcers can be enrolled as long as the ulcers didn’t cause bleeding or any major intervention 
  • Helicobacter pylori positive patients must first undergo and complete a course of H. pylori treatment 
  • No history of GI bleeding that required any blood transfusion, endoscopic or operative intervention
  • No stroke history 
  • No concurrent anticoagulation 
  • No history of atrial fibrillation or heart attack 
  • No history of severe hypertension 
  • No chronic daily use of oral steroids 
  • No known allergy to aspirin 
  • No prior cancer within five years other than breast, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 
  • Concurrent enrollment on a non-chemo treatment trial will be allowed as long as that trial allows concurrent daily aspirin use 
  • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Marta Vallee Cobham, RN, BSN
(212) 821-0780
mac2034@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1711018731

ClinicalTrials.gov:

NCT02927249

Status

Open to Enrollment

Age Group

Adult

Sponsor