Research Study Seeking Participants: Low Dose Aspirin for the Prevention of Postpartum Breast Cancer

The purpose of the Targeted Prevention of Postpartum Breast Cancer study is to determine whether low-dose aspirin can affect markers of inflammation in blood and breast tissue and potentially help prevent postpartum-related breast cancers. The postpartum period is associated with increased inflammation in the breast, which may contribute to higher cancer risk during this time. By studying how aspirin influences these inflammatory pathways, we aim to better understand whether a widely available, low-cost medication could play a role in cancer prevention.

• Who can participate in this study?

Patients 45 years of age or younger who have had at least one child in the past ten years and have not had invasive breast cancer or ductal carcinoma in-situ (DCIS) may be eligible to participate.

• If you agree to be in the study, what will you do?

Before beginning the study, we will explain this study to you and ask you to sign an informed
consent form. Next, you will provide blood and urine samples for research and undergo a research biopsy of the breast.

Then, you will take a single, low-dose aspirin ("baby aspirin") tablet every day for about 6 weeks. You will complete a diary about aspirin intake and complete a questionnaire.

After 6 weeks, you will donate blood and urine again and undergo a second research biopsy. Researchers will compare the immune factors in the pre-and post-aspirin blood, urine, and tissues. You will receive
remuneration for participation.

• Are there any risks involved?

The risks or this study include the following:

• • There may be a risk of bleeding when taking aspirin.
  • There may be a risk or discomfort from the blood draws.
  • There may be risks of discomfort, bruising. or bleeding with the research biopsies.

• How will you benefit from being in the study?

This study may not make your health better. Although no direct health benefit is guaranteed, it is hoped
that this study will produce information that may lead to a more effective approach for preventing
cancer among young women.

• In what ways could having a broad representation of participants improve the quality of the study?

Broad representation among participants is essential to the quality and relevance of this research. Postpartum-related breast cancer affects individuals across racial, ethnic, and socioeconomic groups. Having people represented from different backgrounds allows us to better understand biologic variation, ensures findings are generalizable, and identifies prevention strategies that are relevant and effective for all populations. Community engagement is critical to achieving these goals.

Learn more

If you have any questions about the study, please contact the study coordinator Frances Laboy at FLAQHSCS@mayo.edu. You can also contact the principal investigator of this study, Kathryn J. Ruddy, M.D., at Ruddy.Kathyrn@mayo.edu with any questions or concerns.