Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention

NCT02295059 | Active Not Recruiting DMC

• 2 other identifiers: 164211R01CA164019-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to determine biological changes associated with a low vs high dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over 12 months in women at risk for recurrent breast cancer. The objectives of the trial are to develop mammary epithelial, adipose tissue specific markers of exposure and response to omega 3 fatty acid supplements that can be carried forward into definitive intervention trials of omega 3 fatty acids for breast cancer prevention. The investigators will randomize 80 subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast cancer to either a high or low dose of omega 3 fatty acids. Using fine needle aspiration to procure cellular samples of breast epithelial and adipose tissue, the investigators will determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.

Conditions

Breast Cancer

Keywords

Breast cancer; ERPR negative; HER-2/neu overexpression positive or negative

Outcome Measures

Primary Outcomes (1)

• Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue

  Biomarker

  Baseline to up to 12 months

Secondary Outcomes (2)

• Changes in cytomorphology and/or cell proliferation of mammary epithelial cells

  Baseline to up to 12 months

• Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue

  Baseline to up to 12 months

Study Arms (2)

Omega 3 fatty acids - high dose

EXPERIMENTAL

\~5 g EPA+DHA in 5 capsules per day

Dietary Supplement: omega 3 fatty acids

Omega 3 fatty acids - low dose

EXPERIMENTAL

\~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day

Dietary Supplement: omega 3 fatty acids

Interventions

omega 3 fatty acids DIETARY_SUPPLEMENT

supplied as soft gelatin capsules for oral administration

Also known as: fish oil, eicosapentaenoic acid, docosahexaenoic acid

Omega 3 fatty acids - high dose; Omega 3 fatty acids - low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior diagnosis of Stage 0 to III breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy.
• Completion of chemotherapy or trastuzumab for \> six months and of radiation therapy for \> 2 months, as applicable and 5 years or less from completion of standard therapy.
• Greater than 1 year from pregnancy, lactation.
• Mammogram within the eight months prior to study enrollment that is not suspicious for breast cancer (ACR Class I-III).

You may not qualify if:

• Other current malignancy or metastatic malignancy of any kind.
• Ongoing chemotherapy, radiation therapy, or other cancer-related treatment.
• Subjects on Coumadin or other anticoagulants.
• Subjects with breast implants.
• Subjects who have had radiation to both breasts or who have undergone bilateral mastectomies.
• Barriers to fine needle aspiration sampling of breast adipose tissue and/or parenchymal breast tissue, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose/parenchymal tissue for adequate fine needle aspiration (FNA) sampling.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements.
• Chronic use of omega 3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega 3 fatty acid supplements.
• Pregnant or nursing women.
• Known sensitivity or allergy to fish.
• Subjects on a standing regimen of full dose aspirin (greater than 325 mg/day), NSAIDs (nonsteriodal anti inflammatory drug) or NSAID-containing products.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Frankhouser DE, DeWees T, Snodgrass IF, Cole RM, Steck S, Thomas D, Kalu C, Belury MA, Clinton SK, Newman JW, Yee LD. Randomized dose-response trial of n-3 fatty acids in hormone receptor negative breast cancer survivors - impact on breast adipose oxylipin and DNA methylation patterns. Am J Clin Nutr. 2025 Jul;122(1):70-82. doi: 10.1016/j.ajcnut.2025.04.021. Epub 2025 Apr 25.

  PMID: 40288580 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fatty Acids, Omega-3; Fish Oils; Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Eicosanoids

Study Officials

• Lisa D Yee, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: November 20, 2014
• Study Start: August 9, 2017
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 22, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)