Page 11 - Delaware Medical Journal - September/October 2018

CANCER CLINICAL TRIAL
PROTOCOL OF THE MONTH
Alliance A011502: A randomized phase 111 double blinded placebo-controlled trial of aspirin as adjuvant
therapy for HER 2 negative breast cancer: the ABC trial
Objectives of the trial are:
Primary Objective:
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.
Secondary Objective:
• To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: • Distant disease-free survival
• Overall survival
• Cardiovascular disease
• To compare the toxicity and adherence of aspirin versus placebo
• To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers.
• To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation for whom there is greater benefit of aspirin versus placebo upon iDFS.
Translational Research Objectives Eligibility
• Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high-risk node negative (defined as ER and PR negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence. Patients with pN1mic are eligible.
• Bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility.
• 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.
• 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.
• Patients must be enrolled within 1 year after diagnosis.
• Any ER/PgR status allowed. Age ≥18 and < 70 years of age. Zubrod Performance status 0-2..
• Patients must have adequate CBC and bone marrow function
Treatment: Protocol treatment is to begin ≤ 28 days of registration/randomization. This is a double blinded, placebo controlled trial. • Aspirin/Placebo: One 300 mg tablet orally Daily x 5 years
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | September/October 2018 | Vol. 90 | No. 7 231