Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

NCT05557877 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC220301R01CA26239322-000606
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in pregnancy-related breast cancer (PRBC) score

  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.

  Up to 30 days

Secondary Outcomes (1)

• Change in postpartum involution (PPI) signature score

  Up to 30 days

Other Outcomes (3)

• 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) lobules

  Up to 30 days

• Change in serum C-reactive protein (CRP), estrogens, insulin/insulin-like growth factors (IGFs), and adipokines

  Up to 30 days

• Changes in tissue and urine prostaglandins (PGs) and PGE2

  Up to 30 days

Study Arms (1)

Prevention (low-dose aspirin)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Low-Dose Aspirin; Other: Questionnaire Administration; Procedure: Biopsy

Interventions

Questionnaire Administration OTHER

Ancillary studies

Prevention (low-dose aspirin)

Biopsy PROCEDURE

Undergo breast biopsy

Also known as: Bx

Prevention (low-dose aspirin)

Biospecimen Collection PROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Prevention (low-dose aspirin)

Low-Dose Aspirin DRUG

Given PO

Also known as: Baby Aspirin

Prevention (low-dose aspirin)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 30 days prior to registration
• REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< days prior to registration)
• REGISTRATION: Negative pregnancy test done =\< 14 days prior to registration
• REGISTRATION: Willing to use contraception while on treatment
• REGISTRATION: Provide written informed consent

You may not qualify if:

• 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)
• REGISTRATION: Co-morbid illnesses/conditions which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• REGISTRATION: Any contraindication to aspirin use including but not limited to:
• Bleeding disorders (e.g., hemophilia)
• Stomach or intestinal bleeding =\< 6 months prior to registration
• Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Mayo Clinic: lead

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

SUSPENDED

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling; Aspirin; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Kathryn J. Ruddy, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: March 9, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (4)