Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05557877
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 9, 2023
Status verified
May 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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.

Primary Outcome Measure

Change in pregnancy-related breast cancer (PRBC) score [ Time Frame: Up to 30 days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Santo Maimone IV, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Jessica M
[email protected]
317-278-6706
Tarah Ballinger, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Kathryn J. Ruddy, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Joshua Carino
[email protected]
919-445-0472
Kristalyn Gallagher, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLIndiana University Simon Comprehensive Cancer Center· Indianapolis, INMayo Clinic in Rochester· Rochester, MNUniversity of North Carolina· Chapel Hill, NC

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