Not Yet RecruitingPhase 2

Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors

United States35 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 therapy is planned, including but not limited to endocrine therapy, chemotherapy, anti-HER2 therapy, and immunotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Bilateral breast cancer and/or multifocal, multicentric disease is allowed. * Appropriate pretreatment evaluations for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup: history/physical examination, including breast exam (inspection and palpation of the breasts), within 30 days prior to study entry. * Patients with a prior history of breast cancer will be considered eligible. * Surgical candidacy as determined by the treating physician. * Patient must provide study-specific informed consent prior to study entry or have a legally authorized representative provide consent. Exclusion Criteria: * American Joint Committee on Cancer (…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is focused on studying how omega-3 fatty acids change the lipid makeup of breast tumors — since it's a Phase 2 study that hasn't started recruiting yet, does it make sense for me to wait and see if I qualify, or would delaying any current treatment plan be a concern?
2The trial is measuring specific lipid species in breast tumors, which sounds like it involves tumor tissue analysis — can you help me understand what kinds of procedures or biopsies might be required, and how that fits with what I'm already going through?
3Since this is a Phase 2 trial studying omega-3 PUFAs in breast tumors, what does that phase tell us about how much is already known about the safety and potential effects of this approach in breast cancer patients specifically?
4Given that this study isn't recruiting yet, is there a standard-of-care treatment I should be starting now, and would participating in this trial later potentially conflict with or complement that path?
5Are there other ongoing or available trials or treatments targeting tumor biology that I should be comparing this omega-3-focused study against before deciding whether to pursue it?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lipid species in primary breast tumors

Timeframe: Up to 32 weeks

Trial details

NCT IDNCT07643428

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Medical College of Wisconsin Cancer Center Clinical Trials Office

866-680-0505 cccto@mcw.edu

View on ClinicalTrials.gov More Breast Cancer trials