This is a single-arm Phase 2 interventional treatment study to investigate changes in tissue lipidomes with omega-3 polyunsaturated fatty acids (PUFA) supplementation and correlations with pathological response in patients with early-stage breast cancer. Patients will be treated with a dietary supplement enriched with omega-3 PUFA (O3Supp) for 4 to 28 weeks prior to surgical resection of a breast tumor(s). Concurrent standard-of-care neoadjuvant treatment with clinically indicated systemic agents (such as chemotherapy, endocrine therapy, anti-HER2 therapy, immunotherapy) is allowed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Subjects will take six (6) soft gel capsules daily.
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Lipid species in primary breast tumors
The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.
Time frame: Up to 32 weeks
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