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RecruitingAccepts healthy volunteersPhase 2

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Mayo Clinic · with National Cancer Institute (NCI) · NCT05557877

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
60
US sites recruiting
4
Study start
March 9, 2023
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Biospecimen Collection; Low-Dose Aspirin; Questionnaire Administration; Biopsy

Conditions: Breast Carcinoma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 =\< 90 days prior to registration)
  • REGISTRATION: Platelet count >= 100,000/mm\^3 (obtained =\< 90 days prior to registration
  • REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< 90 days prior to registration)
  • REGISTRATION: Negative pregnancy test done =\< 15 days prior to registration
  • REGISTRATION: Willing to use contraception while on treatment
  • REGISTRATION: Provide written informed consent
  • REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
  • REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
  • REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
  • REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

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)
  • 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)
  • REGISTRATION: Currently taking anticoagulants
  • REGISTRATION: Any prior or current malignancy requiring prior or current systemic therapy
  • REGISTRATION: Currently pregnant or planning to become pregnant in the next 90 days
  • REGISTRATION: Post-menopausal:
  • Prior bilateral surgical oophorectomy or
  • No menses for > 1 year with estradiol levels within postmenopausal range, according to institutional standard
  • REGISTRATION: Known or suspected active breast infection

Recruiting US locations

  • Mayo Clinic in Florida

    Jacksonville, FL 32224-9980

    Site contact: Clinical Trials Referral Office · 855-776-0015 · mayocliniccancerstudies@mayo.edu

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, IN 46202

    Site contact: Jessica M · 317-278-6706 · jlm41@iu.edu

  • Mayo Clinic in Rochester

    Rochester, MN 55905

    Site contact: Clinical Trials Referral Office · 855-776-0015 · mayocliniccancerstudies@mayo.edu

  • University of North Carolina

    Chapel Hill, NC 27599

    Site contact: Ana Gallegos · 919-966-4432 · Ana_Gallegos@med.unc.edu

Study contacts (from the official record)

  • Clinical Trials Referral Office · 855-776-0015 · mayocliniccancerstudies@mayo.edu
All pregnancy studies in Florida →
Low Dose Aspirin for the Prevention of Postpartum Related Breast… (NCT05557877) | Bored Studies