Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT02295059
Eligibility Criteria:
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 5 years or less from completion of standard therapy.
* Greater than 1 year from pregnancy, lactation.
* Mammogram within the eight months prior to study enrollment that is not suspicious for breast cancer (ACR Class I-III).
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.
* Barriers to fine needle aspiration sampling of breast adipose tissue and/or parenchymal breast tissue, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose/parenchymal tissue for adequate fine needle aspiration (FNA) sampling.
* 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 (greater than 325 mg/day), NSAIDs (nonsteriodal anti inflammatory drug) or NSAID-containing products.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02295059
Study Brief:
Protocol Section:
NCT02295059