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

• ClinicalTrials.gov Identifier: NCT02295059
• Recruitment Status: Active, not recruiting
• First Posted: November 20, 2014
• Last Update Posted: February 17, 2021
• Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): City of Hope Medical Center

Tracking Information

• First Submitted Date: October 14, 2014
• First Posted Date: November 20, 2014
• Last Update Posted Date: February 17, 2021
• Actual Study Start Date: August 9, 2017
• Estimated Primary Completion Date: November 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 5, 2019)

Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [ Time Frame: Baseline to up to 12 months ]

Biomarker

• Original Primary Outcome Measures (submitted: November 17, 2014): Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [ Time Frame: Baseline to up to 12 months ]

Current Secondary Outcome Measures (submitted: March 5, 2019)

• Changes in cytomorphology and/or cell proliferation of mammary epithelial cells [ Time Frame: Baseline to up to 12 months ]
  Biomarker
• Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue [ Time Frame: Baseline to up to 12 months ]
  Biomarker

Original Secondary Outcome Measures (submitted: November 17, 2014)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
• Official Title: Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Breast Cancer

Intervention

Dietary Supplement: omega 3 fatty acids

supplied as soft gelatin capsules for oral administration

Other Names:

• fish oil
• eicosapentaenoic acid
• docosahexaenoic acid

Study Arms

• Experimental: Omega 3 fatty acids - high dose
  ~5 g EPA+DHA in 5 capsules per day
  Intervention: Dietary Supplement: omega 3 fatty acids
• Experimental: Omega 3 fatty acids - low dose
  ~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day
  Intervention: Dietary Supplement: omega 3 fatty acids

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 17, 2014): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2021
• Estimated Primary Completion Date: November 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02295059
• Other Study ID Numbers: 16421; 1R01CA164019-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: City of Hope Medical Center
• Study Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Lisa D Yee, MD; City of Hope Medical Center

• PRS Account: City of Hope Medical Center
• Verification Date: February 2021