Health TrialsbyHealthPanel

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

ConditionBreast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood

  • Low-Dose Aspirin

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Biopsy

    Procedure/Surgery

    Undergo breast biopsy

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Prevention (low-dose aspirin)Experimental treatment 4 interventions

Trial outcomes

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.

Time frame
Up to 30 days

Secondary outcomes

1

Change in postpartum involution (PPI) signature score

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

Time frame
Up to 30 days

Other outcomes

1

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

The change in percent of positive epithelial pre- and post-intervention will be assessed for each person.

Time frame
Up to 30 days
2

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

Serum values will be measured pre- and post-intervention for each person.

Time frame
Up to 30 days
3

Changes in tissue and urine prostaglandins (PGs) and PGE2

PGs will be measured pre- and post-intervention for each person.

Time frame
Up to 30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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