Breast Cancer
Conditions
Keywords
omega-3 Polyunsaturated fatty acids
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.
Interventions
DRUGMini rTG OMEGA-3 Fish Oil
Subjects will take six (6) soft gel capsules daily.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid species in primary breast tumors | Up to 32 weeks | The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors. |
Countries
United States
Contacts
CONTACTMedical College of Wisconsin Cancer Center Clinical Trials Office
PRINCIPAL_INVESTIGATORLubna Chaudhary, MD, MS
Medical College of Wisconsin
Outcome results
None listed