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

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

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Trial Information

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

Inclusion Criteria

Inclusion Criteria

- Subjects must be premenopausal and between the ages of 25 and 54 and must have had a
menstrual period within the past 12 months. Women who are not menstruating regularly
due to use of certain types of contraceptives may be entered with restrictions. Their
estrogen progesterone, and FSH levels must be documented at baseline RPFNA and their
off study RPFNA must take place at a similar portion of their cycle (high or low
progesterone levels). In order to do this a serum progesterone will have to be
obtained ~ 4 weeks before planned RPFNA and again 2 weeks later such that the RPFNA
can be performed in the same phase of the "cycle" as baseline.

- 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 3X the average risk for a woman of the same age
using either the Surveillance Epidemiology and End Results (SEER, database or the NCI Breast Cancer Risk Assessment Tool
(, or 10 yr Tyrer-Cuzick risk 2x population risk as listed
in model, or RPFNA atypia

- BMI <40 Kg/m3

- 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

- 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. If not using an oral, vaginal, or topical contraceptive, must be
willing to actively use barrier methods of contraception to prevent pregnancy.

- 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

- 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 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
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 contralateral
(uninvolved breast) will be studied by RPFNA. The subject may not have had any
radiation therapy to the contralateral breast to be studied

- Subjects > 40 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. Subjects of sufficient age and/or risk for a baseline
mammogram 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 14 or higher). There must be ≥500
epithelial cells on the slide for cytomorphology and evidence of proliferation by
Ki-67 staining. There must be sufficient reserved methanol- formalin-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
conclusion. Baseline urine sample will in part be used to document that subject is
not pregnant.

- Subjects must be willing to complete questionnaires regarding diet and supplement
use, quality of life, 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 this
includes pregnancy, lactation, or stopping or starting hormonal contraceptives..

- Women who have taken omega 3 fatty acid supplements within 3 weeks prior to their
baseline RPFNA.

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

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 premenopausal women under age 55.

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 Center Kansas City, Kansas  66160-7353