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Clinical Trials/NCT07643428
NCT07643428Not yet recruitingPhase 2

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

Medical College of Wisconsin1 site in 1 country35 target enrollmentStarted: September 1, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
35
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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 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
  • •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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lubna Chaudhary

Associate Professor

Medical College of Wisconsin

Study Sites (1)

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