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Non-Steroidal Anti-Inflammatory Drug

Low-Dose Aspirin for Breast Cancer Prevention

Phase 2

Recruiting

Led By Kathryn J Ruddy

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 45 years

Hemoglobin >= 9.0 g/dL, Platelet count >= 100,000/mm^3, Serum creatinine =< 2.0 mg/dl, Negative pregnancy test done within 14 days prior to registration

Must not have

Currently taking anticoagulants

Any contraindication to aspirin use including bleeding disorders, stomach or intestinal bleeding within 6 months prior to registration, known allergy to other NSAIDs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre- vs. post-intervention up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether low-dose aspirin can reduce inflammation in postpartum patients with benign breast disease, which may prevent breast cancer.

Who is the study for?

This trial is for postpartum women aged 18-45 with benign breast disease who've had a live birth within the last 10 years. They must have hemoglobin levels >=9.0 g/dL, platelet count >=100,000/mm^3, serum creatinine =<2.0 mg/dl, and not be pregnant or planning pregnancy soon. Participants should not be on aspirin/NSAIDs or have any contraindications to aspirin use.

What is being tested?

The study tests if low-dose aspirin can change inflammation markers in blood/tissue which might prevent breast cancer after childbirth. It involves biospecimen collection, questionnaires, and ultrasound-guided biopsies to monitor effects.

What are the potential side effects?

Potential side effects of low-dose aspirin may include increased risk of bleeding, stomach issues like ulcers or heartburn, allergic reactions in those sensitive to NSAIDs, and possibly bruising more easily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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My blood work is within normal ranges and I am not pregnant.

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My breast disease has been confirmed as non-cancerous through testing.

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I do not have an active breast infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on blood thinners.

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I don't have allergies to NSAIDs, bleeding disorders, or recent stomach bleeds.

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I am post-menopausal, either through surgery or naturally for over a year.

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I am currently on medication to prevent breast cancer.

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I cannot take aspirin due to health reasons.

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I have or had cancer that needed treatment with medication.

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I have or might have a breast infection.

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I have a history of breast cancer or DCIS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre- vs. post-intervention up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre- vs. post-intervention up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- vs. post-intervention up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pregnancy-related breast cancer (PRBC) score

Secondary study objectives

Change in postpartum involution (PPI) signature score

Other study objectives

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

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

Body Weight Changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (low-dose aspirin)Experimental Treatment4 Interventions

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 ultrasound guided breast biopsy as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 12Eligibility criteria met