Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Omega-3 Fatty Acids in Preventing Recurrence in Patients with Hormone Receptor-Negative or HER2-Positive Stage 0-III Breast Cancer That Have Completed Treatment

Protocol: OSU-13130

Full Title

Omega-3 fatty acids and ERPR(-) and HER-2/neu(+) breast cancer prevention

Purpose

This randomized clinical trial studies omega-3 fatty acids in preventing the return of cancer (recurrence) in patients with hormone receptor-negative or human epidermal growth factor receptor (HER2)-positive stage 0-III breast cancer that have completed treatment. Omega-3 fatty acid may help prevent breast cancer from forming in patients at risk for recurrence.

Study Objective

PRIMARY OBJECTIVES:

I. Modify the content of fatty acid metabolites (e.g. prostaglandin [PG]E2, PGE3) in breast adipose tissue samples obtained by fine needle aspiration at baseline, 3, 6, 9 and 12 months in a dose, time dependent fashion.

II. Modulate cytomorphology and/or cell proliferation of mammary epithelial cells obtained by random periareolar fine needle aspiration (RPFNA) at baseline, 6 and 12 months with correlation to breast adipose tissue docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), omega-3:omega-6 ratio and dose over time.

III. Modify the state of promoter deoxyribonucleic acid (DNA) methylation of p16, glutathione peroxidase 3 (plasma) (GPX3), and phosphatase and tensin homolog (PTEN) in mammary epithelial and adipose tissue samples at 0, 6 and 12 months of omega-3 polyunsaturated fatty acids (PUFA) treatment in a dose, time dependent fashion.

IV. Modulate pro-inflammatory (e.g. COX-2, interleukin [IL]-6, tumor necrosis factor [TNF]-alpha [a]) and anti-inflammatory/antioxidant (e.g. PTEN, GPX3, heme oxygenase [decycling] 1 [HMOX1]) gene expression patterns in breast adipose tissue samples obtained by fine needle aspiration (FNA) by quantitative real time-polymerase chain reaction (RT-PCR).

SECONDARY OBJECTIVES:

I. Evaluation of possible associations between breast adipose tissue or erythrocyte membrane fatty acids (e.g. EPA, DHA and/or omega-3:omega-6 ratio), physical factors such as body mass index (BMI), dietary information, HER-2/neu overexpression and biomarkers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive high-dose omega-3 acid orally (PO) once daily (QD) for 12 months.

ARM II: Patients receive low-dose omega-3 acid PO QD and placebo PO QD for 12 months.

Are you eligible?

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 2 years or less from completion of standard therapy

Greater than 1 year from pregnancy, lactation

Mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the Stefanie Spielman Comprehensive Breast Center or the James Cancer Hospital within the six months prior to study enrollment that are not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered following a negative biopsy

Must be willing to undergo fine needle aspiration of the contralateral breast for breast adipose tissue at 0, 3, 6, 9 and 12 months of the study and breast epithelial tissue samples at 0, 6 and 12 months of study

Must be willing to have about 30 ml of blood drawn at 0, 6 and 12 months and about 5-10 ml of blood at 3 and 9 months

No history of diabetes mellitus or stroke, or bleeding tendency

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (fully active or restricted only in physically strenuous activity)

Hemoglobin >= 9 g/dL

Platelets >= 100,000/mm^3

Fasting blood glucose =< 115 mg/dL

Transaminases (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =< 1.5 x upper limit of normal (ULN)

Negative pregnancy test for women of childbearing potential

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

Subjects with insufficient breast adipose tissue and/or parenchymal breast tissue/breast density for adequate FNA sampling as determined by clinical examination and/or mammography

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 (>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products

Breast Cancer