Actively Recruiting

Phase 2
Age: 45Years - 74Years
FEMALE
Healthy Volunteers
NCT06195306

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-14

66

Participants Needed

3

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 74Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 to 74 years
  • Female who is postmenopausal defined by either removal of ovaries or amenorrhea for 12 months or more with appropriate hormone levels
  • Overweight or obese with body mass index (BMI) 25 kg/m2 or higher
  • Willing to undergo fasting blood draw and breast tissue sampling by fine needle aspiration
  • At increased risk of breast cancer based on personal history, high mammographic density, genetic test results, risk calculation tools, or family history
  • Liver function within acceptable limits (bilirubin, AST, ALT)
  • HIV-positive patients on effective treatment with undetectable viral load are eligible
  • Patients cured or effectively treated for hepatitis B, hepatitis C, or herpes simplex virus are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Must have at least one unaffected untreated breast suitable for fine needle aspiration
  • Ability to understand and sign informed consent
  • Recent screening mammogram within 12 months with appropriate BIRADS score
  • Confirmation that fasting blood sample was collected and archived for study analysis
Not Eligible

You will not qualify if you...

  • Bilateral breast implants
  • Prior invasive breast cancer or invasive uterine cancer
  • Other invasive cancers within past 2 years without completed therapy
  • Currently breastfeeding or nursing within past 12 months
  • Diabetes requiring pharmacologic treatment
  • History of deep vein thrombosis, pulmonary embolus, or stroke
  • Prior gastric bypass surgery
  • Chronic liver disease including NASH or cirrhosis
  • Pathogenic germline mutation in BRCA1 or TP53 genes
  • Current use of prescription anticoagulants such as warfarin, rivaroxaban, or apixaban
  • Unable or unwilling to stop daily aspirin use before breast tissue sampling
  • Use of levonorgestrel intrauterine device less than 2 years or planned removal within 6 months
  • Current hormone therapy (except vaginal estrogen)
  • Prior tamoxifen, aromatase inhibitor, or selective estrogen receptor degrader use over 2 months
  • Omega-3 supplements over 1 gram daily within last 6 months
  • Use of prescription immunosuppressive drugs
  • Use of CYP3A4 strong inducers or planned use of certain diabetes drugs
  • Participation in other investigational drug studies
  • Allergic reactions to tamoxifen or omega-3 fatty acids
  • Uncontrolled illness or psychiatric/social issues limiting study compliance

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University of Kansas Cancer Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

2

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

3

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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