Status:
UNKNOWN
Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ran...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00114296
Start Date
April 1 2005
Last Update
September 17 2013
Active Locations (1)
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1
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048