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Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids

Phase 2
25 Years
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids

Inclusion Criteria

Inclusion Criteria

- Subjects must be postmenopausal and between the ages of 25 and 69 years. Menopause is
defined by no menstrual period for more than one year and intact uterus and ovaries,
or women with intact ovaries but without a uterus and age 50 and over, or a woman
with both estradiol and FSH in the postmenopausal range or any woman who has had her
ovaries removed.

- Subjects must be at increased risk for breast cancer on the basis of at least one of
the following criteria:

- A five-year Gail risk of ≥ 1.67% or ≥ 2X the average risk for a woman of the
same age using either the Surveillance Epidemiology and End Results (SEER, database, the NCI Breast Cancer Risk Assessment Tool
(, or the IBIS Risk Evaluator (http://www.emstrials.
org/riskevaluator/), or a ten-year Tyrer-Cuzick model risk of 2x that of the
population risk.

- A first degree relative with breast cancer under the age of 60 or multiple
second degree relatives with breast cancer.

- Multiple prior biopsies or at least one prior biopsy exhibiting atypical
hyperplasia (AH), LCIS, DCIS.

- RPFNA evidence of hyperplasia with atypia within the last three years;

- Chest or neck radiation before age 30;

- Mammographic breast density by visual estimate equals or exceeds 50%.

- Subjects must be willing to continue the same hormonal milieu present at baseline
throughout trial (Cannot start or stop any type of hormone replacement therapy with
the exception of vagifem or estring).

- Six months or more must have elapsed from completion of a prevention intervention
trial (with exception of a weight reduction trial), ingestion of a selective estrogen
receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker
assessment. .

- Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must
have been counseled about appropriate standard prevention therapies such as tamoxifen
or raloxifene and are either not eligible or are not interested in standard
prevention therapies. Women with DCIS must have had appropriate local therapy
(lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two
months must have elapsed from surgery and/or radiation therapy to the involved
breast. Only the contra-lateral (uninvolved breast) will be studied by RPFNA. The
subject may not have had any radiation therapy to the contra-lateral breast to be

- Subjects must have had a screening mammogram within 6 months of entering the
interventional portion of the study and read as not suspicious for breast cancer or
if suspicious must have completed all suggested tests including biopsy and found to
have no evidence of cancer. Women must be willing to have an off-study mammogram
performed 6 months after study entry.

- Subjects must have had an RPFNA of the breast within six months prior to entering the
intervention portion of the study and be willing to have another RPFNA at ~6.5 months
after starting Lovaza™.

- Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with
atypia or borderline atypia (Masood score > 13). There must be ≥500 epithelial cells
on the slide for cytomorphology. There must be sufficient reserved methanolformalin-
fixed material for RT-qPCR. Frozen tissue must also have been obtained for fatty acid
analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.

- Subjects must be willing to undergo phlebotomy at baseline and 6 months and 6.5
months. Approximately 3 tablespoons of blood will be obtained at baseline and 6
months and 6.5 months or 6 tablespoons if the subject decides to participate in the
optional monocyte cytokine release assay .

- Subjects must produce a spot urine sample at baseline, 6 months, and at study

- Subjects must be willing to undergo measurement of height, weight, and BMI and
undergo body composite analysis (DEXA) at initiation and conclusion of intervention.

- Subjects must be willing to complete questionnaires regarding diet and supplement
use, quality of life as well as relevant family history personal health and
reproductive history and medications at initiation and conclusion of the
intervention. Subjects must be willing to sign an informed consent for the entire
study and separate consent for repeat RPFNA.

Exclusion Criteria

- Women that have had a metastatic malignancy of any kind.

- Women that have had prior invasive breast cancer, diagnosed or treated within the
past five years.

- Women who are currently taking anticoagulants.

- Women who have breast implants.

- Women who have undergone change in their hormonal milieu in the past 6 months.

- Women who have taken omega 3 fatty acid or flaxseed supplements within 3 weeks prior
to their baseline RPFNA or women who have taken high dose omega 3 within the past
three months.

- Women who regularly take NSAIDS (>7 tablets weekly).

- Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention
or other investigational drug study within six months prior to baseline FNA.

- Women who have abnormal renal or hepatic function at baseline, defined as blood
chemistry values clinically significantly outside of normal institutional ranges.

- Women who have a history of an allergy, including hives, to fish products.

- Women who have a BMI of 40 Kg/m2 or greater.

Inclusion of Women and Minorities This study utilizes women at increased risk for breast
cancer. Subjects recruited from an established cohort of women followed in the Breast
Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is
similar to our hospital demographics. Males are not included due to the low absolute risk
of breast cancer, and the difficulty of performing RPFNA on the male breast.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To determine the feasibility of an intervention of Lovaza™ 4 grams per day

Outcome Description:

To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.

Outcome Time Frame:

6 month visit

Safety Issue:


Principal Investigator

Carol Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Human Subjects Committee

Study ID:




Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of Kansas Medical CenterKansas City, Kansas  66160-7353