Cancer Lipidome Adaptation and Resculping Through Omega-3... | NCT07643428

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

NCT07643428

Sponsor

Medical College of Wisconsin

Status

Not yet recruiting

Last Update Posted

Jun 11, 2026Actual

Enrollment

35Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Mini rTG OMEGA-3 Fish Oil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Jun 1, 2028Estimated

Completion Date

Jun 1, 2028Estimated

First Submitted Date

Jun 7, 2026

First Submission Date that Met QC Criteria

Jun 7, 2026

First Posted Date

Jun 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2026

Last Update Posted Date

Jun 11, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mini rTG OMEGA-3 Fish Oil	Drug	Subjects will take six (6) soft gel capsules daily.	Dietary Intervention

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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 (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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases