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Clinical Trial Summary

This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) patients with benign breast disease 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.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Pre- versus (vs) post-intervention change in postpartum-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 ultrasound guided breast biopsy as clinically indicated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05557877
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 2
Start date February 14, 2023
Completion date January 30, 2027

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