Breast CancerNCT02295059
Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
A study testing omega 3 fatty acids in people with Breast Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- omega 3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Aug 2017to 5 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention
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.
Read the detailed description
The study aims to determine biological changes that occur with a 12 month intervention of low (~0.9 g EPA+DHA/day) vs high dose (~5.4 g EPA+DHA/day) of omega 3 polyunsaturated fatty acids (PUFAs) in women survivors of hormone unresponsive breast cancer. The objectives of the trial are to develop unique 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 EPA, DHA/omega 3 PUFAs 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 PUFAs. 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
- Being tested
- omega 3 fatty acids
- Keywords
- Breast cancer, ERPR negative, HER-2/neu overexpression positive or negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 fatty acidsDietary supplement
Also called fish oil, eicosapentaenoic acid, docosahexaenoic acid
supplied as soft gelatin capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 fatty acids - high dose | Experimental | ~5 g EPA+DHA in 5 capsules per day Receives: 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 Receives: Dietary Supplement: omega 3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
Biomarker
Measured: Baseline to up to 12 months
Secondary outcomes (2)
Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
Biomarker
Measured: Baseline to up to 12 months
Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
Biomarker
Measured: Baseline to up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start9 Aug 2017
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa D Yee, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295059
- Sponsor's protocol ID
- 16421
- Other IDs
- 1R01CA164019-01A1
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2014
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frankhouser DE, Yin HH, Belury MA, Newman JW, Yee LD. High- versus low-dose dietary n-3 PUFA treatment produces mixed effects on DNA methylation and epigenetic fidelity in breast adipose tissue. medRxiv [Preprint]. 2026 Mar 22:2026.03.18.26348746. doi: 10.64898/2026.03.18.26348746.
PubMed 41891042Frankhouser 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.
PubMed 40288580
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention
- ClinicalTrials.gov ID
- NCT02295059
- Acronym / sponsor ID
- 16421
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, ERPR negative, HER-2/neu overexpression positive or negative
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to determine biological changes that occur with a 12 month intervention of low (~0.9 g EPA+DHA/day) vs high dose (~5.4 g EPA+DHA/day) of omega 3 polyunsaturated fatty acids (PUFAs) in women survivors of hormone unresponsive breast cancer. The objectives of the trial are to develop unique 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 EPA, DHA/omega 3 PUFAs 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 PUFAs. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 fatty acids - high dose | Experimental | Dietary Supplement: omega 3 fatty acids~5 g EPA+DHA in 5 capsules per day |
| Omega 3 fatty acids - low dose | Experimental | Dietary Supplement: omega 3 fatty acids~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 3 fatty acidsAlso: fish oil, eicosapentaenoic acid, docosahexaenoic acidsupplied as soft gelatin capsules for oral administration | Dietary supplement | Omega 3 fatty acids - high dose, Omega 3 fatty acids - low dose |
Primary outcome
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
Time frame: Baseline to up to 12 months
Biomarker
2 secondary outcomes
Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
Time frame: Baseline to up to 12 months
Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
Time frame: Baseline to up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 41891042Frankhouser DE, Yin HH, Belury MA, Newman JW, Yee LD. High- versus low-dose dietary n-3 PUFA treatment produces mixed effects on DNA methylation and epigenetic fidelity in breast adipose tissue. medRxiv [Preprint]. 2026 Mar 22:2026.03.18.26348746. doi: 10.64898/2026.03.18.26348746.
- Derived from this study: PubMed 40288580Frankhouser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa D Yee, MD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega 3 fatty acids in people with Breast Cancer, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue (time frame: Baseline to up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295059, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.