Your session is about to expire
← Back to Search
Non-Steroidal Anti-Inflammatory Drug
Low-Dose Aspirin for Breast Cancer Prevention
Phase 2
Recruiting
Led By Kathryn J. Ruddy, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- vs. post-intervention up to 30 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 45 years old.
Select...
My blood work is within normal ranges and I am not pregnant.
Select...
My breast disease has been confirmed as non-cancerous through testing.
Select...
I do not have an active breast infection.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pregnancy-related breast cancer (PRBC) score
Secondary outcome measures
Change in postpartum involution (PPI) signature score
Other outcome measures
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
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 PO daily 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 2
~1730
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,034 Total Patients Enrolled
83 Trials studying Breast Cancer
13,810 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,805 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Kathryn J. Ruddy, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken aspirin or NSAIDs recently.I am currently on blood thinners.I don't have allergies to NSAIDs, bleeding disorders, or recent stomach bleeds.I have taken aspirin or NSAIDs recently.I am between 18 and 45 years old.I have had or will have a biopsy for a breast lesion suspected to be benign.I am pre-menopausal according to my own report or doctor's assessment.I am post-menopausal, either through surgery or naturally for over a year.I am currently on medication to prevent breast cancer.There is no tissue sample from a biopsy taken before or within the last 12 months.My blood work is within normal ranges and I am not pregnant.I cannot take aspirin due to health reasons.I have or had cancer that needed treatment with medication.Gave birth to a live baby in the last 10 years.I have or might have a breast infection.My breast disease has been confirmed as non-cancerous through testing.You have received treatment for any other type of cancer.I have a history of breast cancer or DCIS.I do not have an active breast infection.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (low-dose aspirin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research participants are joining this clinical trial?
"That is correct. Based on the information available from clinicaltrials.gov, this study appears to be actively recruiting patients right now. 100 subjects are needed at a single location, and recruitment began on October 7th, 2020."
Answered by AI
Are elderly patients eligible for this particular program?
"This particular trial is only for patients that fall in the age bracket of 18 to 45. However, there are a total of 65 studies involving minors and 2289 trials for senior citizens."
Answered by AI
Is it harmful to take aspirin regularly as a preventative measure?
"Prevention (low-dose aspirin) is in Phase 2 of testing, meaning that while there is evidence suggesting it is safe, none yet supports its efficacy."
Answered by AI
Are people with the specified medical conditions able to enroll in this clinical trial at this time?
"That is correct. The clinical trial was posted on 10/7/2022 and is actively recruiting 100 patients from 1 site, according to the most recent update on 10/10/2022."
Answered by AI
Am I able to help with this research by enrolling in the trial?
"Eligibility criteria for this study includes being female and between 18-45 years old. The research team is looking to enroll around 100 individuals in total."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger