Targeted Prevention of Postpartum-Related Breast Cancer

Mayo Clinic8 sites in 1 country100 target enrollmentMarch 9, 2023

InterventionsBiospecimen Collection Low-Dose Aspirin Questionnaire Administration Biopsy

DrugsLow-Dose Aspirin

Overview

Phase: Phase 2
Intervention: Biospecimen Collection
Conditions: Not specified
Sponsor: Mayo Clinic
Enrollment: 100
Locations: 8
Primary Endpoint: Change in pregnancy-related breast cancer (PRBC) score
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 9, 2023

End Date

January 30, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Mayo Clinic

Responsible Party

Sponsor

Eligibility Criteria

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 correlative research
•REGISTRATION: Age \>= 18 years and =\< 45 years of age
•REGISTRATION: Registration for this study must be completed either =\< one (1) year after the qualifying pre-registration biopsy is performed for this study or =\< one (1) year after collection of the archived tissue (for those who did not have a pre-registration biopsy performed after pre-registration for this study)
•REGISTRATION: Hemoglobin \>= 9.0 g/dL (obtained =\< 30 days prior to registration)

Exclusion Criteria

•PRE-REGISTRATION: History of breast cancer including ductal breast carcinoma in situ (DCIS)
•PRE-REGISTRATION: Received systemic treatment for any other cancer at any time
•PRE-REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within =\< 5 days prior to pre-registration and no more than four doses within =\< 30 days prior to pre-registration)
•PRE-REGISTRATION: Currently taking other agents for the prevention of breast cancer
•PRE-REGISTRATION: Currently taking anticoagulants
•PRE-REGISTRATION: Contraindication for aspirin use
•PRE-REGISTRATION: Known or suspected active breast infection
•REGISTRATION: Known DCIS or invasive cancer
•REGISTRATION: No research tissue available from pre-registration biopsy or from archived tissue (collected =\< 12 months prior to pre-registration)
•REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) (NOTE: no doses within =\< 5 days prior to registration and no more than four doses within =\< 30 days prior to registration)

Arms & Interventions

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 breast biopsy as clinically indicated.

Intervention: Biospecimen Collection

Prevention (low-dose aspirin)

Intervention: Low-Dose Aspirin

Prevention (low-dose aspirin)

Intervention: Questionnaire Administration

Prevention (low-dose aspirin)

Intervention: Biopsy

Outcomes

Primary Outcomes

Change in pregnancy-related breast cancer (PRBC) score

Time Frame: Up to 30 days

Assessed using pre- versus post-treatment PRBC scores. Patients who are eligible, consented, received at least 70% of the study treatment, and provided both a pre- and post-intervention tissue specimen will be evaluated for this outcome.