Targeted Prevention of Postpartum-Related Breast Cancer
Mayo Clinic
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.
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…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION: Age \>= 18 years and =\< 45 years of age * PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints. * PRE-REGISTRATION: Had a live birth =\< 10 years prior to pre-registration * PRE-REGISTRATION: Pre-menopausal according to patient report and/or clinical determination * PRE-REGISTRATION: Provide written informed consent * PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance * PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlati…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- DrugLow-Dose Aspirin
Given PO
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureBiopsy
Undergo breast biopsy
Locations (4)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Indiana University Simon Comprehensive Cancer CenterIndianapolis, Indiana
- Mayo Clinic in RochesterRochester, Minnesota