OncoMatch/Clinical Trials/NCT06195306
Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction
Is NCT06195306 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Omega-3-Acid Ethyl Esters and Tamoxifen for breast atypical hyperplasia.
Treatment: Omega-3-Acid Ethyl Esters · Tamoxifen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Excluded: BRCA1 pathogenic mutation
Pathogenic or likely pathogenic germline mutation in BRCA1
Excluded: TP53 pathogenic mutation
Pathogenic or likely pathogenic germline mutation in TP53
Allowed: ATM germline gene mutation
Germline gene mutation in ATM
Allowed: BARD1 germline gene mutation
Germline gene mutation in BARD1
Allowed: BRCA2 germline gene mutation
Germline gene mutation in BRCA2
Allowed: CDH1 germline gene mutation
Germline gene mutation in CDH1
Allowed: CHEK2 germline gene mutation
Germline gene mutation in CHEK2
Allowed: NF1 germline gene mutation
Germline gene mutation in NF1
Allowed: PALB2 germline gene mutation
Germline gene mutation in PALB2
Allowed: PTEN germline gene mutation
Germline gene mutation in PTEN
Allowed: RAD51C germline gene mutation
Germline gene mutation in RAD51C
Allowed: RAD51D germline gene mutation
Germline gene mutation in RAD51D
Allowed: STK11 germline gene mutation
Germline gene mutation in STK11
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: tamoxifen
Exception: less than 2 months of these drugs must be off for at least 6 months before biomarker screening
Prior treatment with tamoxifen, aromatase inhibitor or selective estrogen receptor degrader for more than 2 months
Cannot have received: aromatase inhibitor
Exception: less than 2 months of these drugs must be off for at least 6 months before biomarker screening
Prior treatment with tamoxifen, aromatase inhibitor or selective estrogen receptor degrader for more than 2 months
Cannot have received: selective estrogen receptor degrader
Exception: less than 2 months of these drugs must be off for at least 6 months before biomarker screening
Prior treatment with tamoxifen, aromatase inhibitor or selective estrogen receptor degrader for more than 2 months
Cannot have received: omega-3 fatty acid supplement
Greater than 1 gram daily of omega-3 fatty acid supplement within the last 6 months
Lab requirements
Liver function
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; Higher total bilirubin levels (≤ 3 mg/dL) can be allowed if due to known benign liver condition, i.e., Gilbert's syndrome
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; Higher total bilirubin levels (≤ 3 mg/dL) can be allowed if due to known benign liver condition, i.e., Gilbert's syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kansas Cancer Center · Kansas City, Kansas
- University of Michigan Rogel Cancer Center · Ann Arbor, Michigan
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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