NCI Community Oncology Research Program - Protocol Summary
Alliance A011502 - "A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR NODE POSTIVE HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Breast Clinical Trial
CANCER TYPE: Stage II
RESEARCH BASE: Alliance
NCT NUMBER: NCT02927249
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UPDATED ON 01/31/2019 (16:12:26)
Breast carcinoma, node positive, HER-2 negative, stage II or III, aspirin 300mg vs. placebo x 5 years. DCP-001 Eligible
Treatment (Supplied drug: aspirin/placebo)
Aspirin 300mg daily for 5 years
Placebo daily for 5 years
- Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence.
- If ER and PR negative, tumor must be node positive or >2 cm and node negative. Patients must be registered within 18 months of diagnosis. pN1mic is eligible. If ER and/or PR positive, tumor must be node positive and within 10 years of diagnosis. pN1mic is eligible.
- 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 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.
- Age > 18 and < 70 years of age.
- 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.
- No history of 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 or clopidogrel or oral direct thrombin 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 invasive malignancy of any type 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.
- Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.