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Breast CarcinomaPhase 2NCT05557877

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

A Phase 2 study testing Biospecimen Collection, Low-Dose Aspirin and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Carcinoma
What is being tested?
Biospecimen Collection, Low-Dose Aspirin and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesUnited States
Study dates
9 Mar 2023to 30 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

5 sites in 1 country

United States5 sites, 4 recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Ana Gallegos, 919-966-4432, Ana_Gallegos@med.unc.edu

    Kristalyn Gallagher, DO

    Recruiting

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Jessica M, 317-278-6706, jlm41@iu.edu

    Tarah Ballinger, MD

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Santo Maimone IV, MD

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Kathryn J. Ruddy, MD

    Recruiting

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

    Terminated

Other trials in United States

About this study

Official title: Targeted Prevention of Postpartum-Related Breast Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Pre- versus (vs.) post-intervention change in post-partum-related breast cancer (PRBC) score.

SECONDARY OBJECTIVE:

  1. Pre- vs. post-intervention change in postpartum involution (PPI) signature score.

EXPLORATORY OBJECTIVES:

  1. 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.

Being tested
Biospecimen Collection, Low-Dose Aspirin, Questionnaire Administration, Biopsy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood

  • Low-Dose AspirinDrug

    Also called Baby Aspirin

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

  • BiopsyProcedure or surgery

    Also called Bx

    Undergo breast biopsy

Study groups in NCT05557877
Study groupRoleWhat they receive
Prevention (low-dose aspirin)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Drug: Low-Dose Aspirin; Other: Questionnaire Administration; Procedure: Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 30 days

Secondary outcomes (1)

  1. Change in postpartum involution (PPI) signature score

    Assessed using pre- and post-intervention PPI signature scores for each person.

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start9 Mar 2023
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557877
Sponsor's protocol ID
MC220301
Other IDs
R01CA262393, 22-000606
Status last verified
Sep 2026
First submitted
23 Sep 2022
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Low-Dose Aspirin and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pregnancy-related breast cancer (PRBC) score (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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