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

NCT07643428 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO00059463
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

omega-3 Polyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 32 weeks

Study Arms (1)

Dietary Intervention

EXPERIMENTAL

Mini rTG OMEGA-3 fish oil is a commercially available dietary supplement in the form of soft gel capsules.

Drug: Mini rTG OMEGA-3 Fish Oil

Interventions

Mini rTG OMEGA-3 Fish Oil DRUG

Subjects will take six (6) soft gel capsules daily.

Dietary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• American Joint Committee on Cancer (AJCC) clinical M1 breast cancer (i.e., with distant metastasis).
• Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
• Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol treatment or providing informed consent.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lubna Chaudhary, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)