Mayo Clinic
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.
Benign Breast Neoplasm
Breast Carcinoma
Breast Fibrocystic Change
Biospecimen Collection
Low-Dose Aspirin
Questionnaire Administration
Ultrasound-Guided Biopsy
Phase 2
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 Type : | Interventional |
Estimated Enrollment : | 100 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | Targeted Prevention of Postpartum-Related Breast Cancer |
Actual Study Start Date : | February 14, 2023 |
Estimated Primary Completion Date : | January 30, 2026 |
Estimated Study Completion Date : | January 30, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Prevention (low-dose aspirin) 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 by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated. |
Procedure: Biospecimen Collection Drug: Low-Dose Aspirin Other: Questionnaire Administration Procedure: Ultrasound-Guided Biopsy |
Ages Eligible for Study: | 18 Years to 45 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Recruiting
Mayo Clinic in Florida
Jacksonville, florida, United States, 32224-9980
Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905