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

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

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.

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.