Breast Cancer Clinical Trial

Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer

Summary

RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer.

PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer.

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Full Description

OBJECTIVES:

Primary

Determine the effects of omega-3 fatty acids on mammographic breast density (MBD) in women at high risk of developing breast cancer.

Secondary

Determine, preliminarily, the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients.
Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients.
Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients.
Determine the effects of this supplement on plasma lipid peroxidation levels in these patients.
Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral placebo three times daily for 12 months.
Arm II: Patients receive oral omega-3 fatty acids three times daily for 12 months.

In both arms, treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

At increased risk of developing breast cancer, as defined by 1 of the following criteria:

5-year Gail risk ≥ 1.7%

Calculated 5-year Gail risk ≥ 5 times the average for age group, as defined by 1 of the following:

At least 0.1% (for patients age 20-29)
At least 1.0% (for patients age 30-39)
At least 1.7% (for patients age 40 and over)
Known BRCA1 or BRCA2 mutation carrier

Family history consistent with hereditary breast cancer, as defined by any of the following:

At least 4 relatives diagnosed with breast cancer at any age
At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger
Breast and ovarian cancer diagnosed in the same relative
At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family
Atypical hyperplasia or lobular carcinoma in situ of the breast by prior biopsy
History of unilateral ductal carcinoma in situ of the breast
History of invasive stage I breast cancer in remission (completed local and systemic standard therapy)
History of ovarian cancer in remission for > 5 years
Baseline mammogram performed within the past 6 months with an interpretation of not suspicious for malignancy (BIRAD 1-3)
Not eligible for OR refused standard breast cancer risk reduction strategies (e.g., prophylactic oophorectomy, prophylactic mastectomy, or tamoxifen)

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal status

Not specified

Performance status

SWOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL

Hepatic

SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Bilirubin ≤ 2.0 times ULN

Renal

Creatinine ≤ 2.0 mg/dL

Other

Not pregnant or nursing
Negative pregnancy test
No underlying medical, psychiatric, or social condition that would preclude study participation
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

More than 6 months since prior and no concurrent hormonal therapy, including any of the following:

Antiestrogens
Estrogen
Selective estrogen-receptor modulators
Progestins
Aromatase inhibitors
Hormonal contraceptives

Radiotherapy

Not specified

Surgery

No prior bilateral mastectomy

Other

More than 3 months since prior and no concurrent chronic (i.e., > 3 times per week) non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, or indomethacin) or cyclooxygenase-2 inhibitors
No prior cancer treatment that would preclude study treatment

Study is for people with:

Breast Cancer

Estimated Enrollment:

80

Study ID:

NCT00114296

Recruitment Status:

Unknown status

Sponsor:

Cedars-Sinai Medical Center

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There is 1 Location for this study

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Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

80

Study ID:

NCT00114296

Recruitment Status:

Unknown status

Sponsor:


Cedars-Sinai Medical Center

How clear is this clinincal trial information?

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