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NCT Number: NCT07643428

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location contact

Lubna Chaudhary, MD, MS

CONTACT

[email protected]

414-805-4600

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mini rTG OMEGA-3 Fish Oil

Drug

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

Primary outcomes

  1. Lipid species in primary breast tumors

    Time frame: Up to 32 weeks

    The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

[email protected]

866-680-0505 ext. 8900

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Acronym: CLARA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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