NCT05557877

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Targeted Prevention of Postpartum-Related Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood
DRUG	Low-Dose Aspirin	Given PO
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Biopsy	Undergo breast biopsy

Timeline

• Start date: 2023-03-09
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2022-09-28
• Last updated: 2026-03-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study