Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT07643428
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Milwaukee, Wisconsin, 53226, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will take six (6) soft gel capsules daily.
Time frame: Up to 32 weeks
The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.
Contact information is provided by the study sponsor or research team.
Medical College of Wisconsin
Other
Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors (CLARA)
Acronym: CLARA
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