RecruitingPhase 2NCT06195306

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

Phase 2 Study of Low Dose Tamoxifen +/- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

66 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a low dose of tamoxifen (a hormone-blocking drug), with or without omega-3 fish oil supplements, can reduce the risk of breast cancer in women who have a higher-than-average chance of developing it. **You may be eligible if...** - You are a postmenopausal woman between the ages of 45 and 65 - You have gone through natural menopause (no period for 12+ months) or had your ovaries removed - You are at elevated risk for breast cancer (your doctor can assess this) **You may NOT be eligible if...** - You are still having regular menstrual periods - You have a personal history of breast cancer or certain other cancers - You are currently on hormone replacement therapy that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREMammography

Undergo mammography

DRUGOmega-3-Acid Ethyl Esters

Given PO

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURERandom Periareolar Fine-Needle Aspiration

Undergo RPFNA

DRUGTamoxifen

Given PO


Locations(3)

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06195306


Related Trials