RightFit
Not yet recruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

WI