Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors (CLARA)
Medical College of Wisconsin
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be ≥18 years of age. * Breast tumor ≥1 cm. * Not currently taking dietary supplements containing fish oil or omega-3 PUFAs. A diet containing fish meat is permitted. * Unilateral and/or bilateral diagnostic breast mammogram and/or ultrasound within 60 days of enrollment. If breast MRI is done per treating physician's discretion, at least one breast imaging modality should be within 60 days of enrollment. * Pathologically proven diagnosis of invasive breast cancer, clinical stage I-III (cT1c-T4, N0-N3, M0). * Concurrent (neoadjuvant) systemic anti-cancer ther…
Interventions
- DrugMini rTG OMEGA-3 Fish Oil
Subjects will take six (6) soft gel capsules daily.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin