Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mini rTG OMEGA-3 Fish Oil.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors (CLARA)
Overview
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.
Interventions
- Drug Mini rTG OMEGA-3 Fish Oil
Subjects will take six (6) soft gel capsules daily.
Primary outcome measures
- Lipid species in primary breast tumors [Time frame: Up to 32 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Froedtert & the Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07643428 · PRO00059463