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A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial
 
Region Sponsors
Mid-Atlantic
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
1284425-3
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Node Positive HER2 Negative Breast Cancer
 
Purpose
This randomized phase III trial studies how well aspirin works in preventing cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 - 69 years
 
Inclusion Criteria
  • Any ER/progesterone receptor (PgR) status allowed
  • Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed, the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration. Concurrent hormonal therapy will be allowed
  • Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days 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
  • Eastern Cooperative Oncology Group (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
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion, endoscopic or operative intervention
  • No history of any prior stroke (hemorrhagic or ischemic)
  • No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors
  • No history of atrial fibrillation or myocardial infarction
  • No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis)
  • No chronic (duration > 30 days) daily use of oral steroids
  • No known allergy to aspirin
  • No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS]) within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study
  • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Node Positive HER2 Negative Breast Cancer
  • HER2
  • Oncology (Adult)
 
KP Clinical Facility
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, RN
-301-816-6768
-Leslie.K.Greenberg@kp.org
-Burke Medical Center


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