Targeted Prevention of Postpartum-Related Breast Cancer
Summary
This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) women planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.
Detailed description
PRIMARY OBJECTIVE: I. Pre- versus (vs.) post-intervention change in post-partum-related breast cancer (PRBC) score. SECONDARY OBJECTIVE: I. Pre- vs. post-intervention change in postpartum involution (PPI) signature score. EXPLORATORY OBJECTIVES: I. Pre- vs. post-intervention change in percent of epithelial cells positive for COX-2, estrogen receptor (ER)/Ki67, gammaH2AX, and p16 in "normal" and in benign breast disease (BBD) lobule. II. Pre- vs. post-intervention change in serum C-reactive protein (CRP), estrogens, insulin/insulin-like growth factors (IGFs), and adipokines. III. Pre- vs. post-intervention changes in tissue and urine prostaglandins (PGs) and PGE2. OUTLINE: Patients undergo standard of care breast biopsy for assessment of abnormalities seen on imaging, as well as collection of blood during screening. If cancer is found, patient is taken off study and treatment options are discussed with treating physician. Patients without a cancer finding on biopsy then receive low-dose aspirin orally (PO) daily and undergo collection of blood on study. Patients may undergo breast biopsy as clinically indicated. After completion of study treatment, patients are followed up at 30 days.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- DrugLow-Dose Aspirin
Given PO
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureBiopsy
Undergo breast biopsy
Outcome measures
Primary
Change in pregnancy-related breast cancer (PRBC) score
Assessed using pre- versus post-treatment PRBC scores. Patients who are eligible, consented, received at least 70% of the study treatment, and provided both a pre- and post-intervention tissue specimen will be evaluated for this outcome.
Time frame: Up to 30 days
Secondary
Change in postpartum involution (PPI) signature score
Time frame: Up to 30 days
Eligibility criteria
Study locations (5)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
University of North Carolina
Chapel Hill, North Carolina, 27599