[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07643428":3,"trial-entities:NCT07643428":94,"trial-summary:NCT07643428":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":17,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":64,"locations":67,"central_contacts":83,"overall_officials":89,"references":92,"see_also_links":93},"NCT07643428","PRO00059463","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)","NOT_YET_RECRUITING","2028-06-01","2026-06","2026-06-11","2026-09-01","Medical College of Wisconsin","OTHER",true,"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.",null,[19],"Breast Cancer",[21],"omega-3 Polyunsaturated fatty acids","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},35,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Mini rTG OMEGA-3 Fish Oil","Subjects will take six (6) soft gel capsules daily.",[35],"Dietary Intervention",[37],{"measure":38,"description":39,"timeFrame":40},"Lipid species in primary breast tumors","The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.","Up to 32 weeks",[],"ALL","18 Years",false,{"inclusion":46,"exclusion":59,"raw_text":63},[47,48,49,50,51,52,53,54,55,56,57,58],"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\u002For bilateral diagnostic breast mammogram and\u002For 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\u002For 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\u002Fphysical 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.",[60,61,62],"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.","Inclusion Criteria:\n\n* Patient must be ≥18 years of age.\n* Breast tumor ≥1 cm.\n* Not currently taking dietary supplements containing fish oil or omega-3 PUFAs. A diet containing fish meat is permitted.\n* Unilateral and\u002For bilateral diagnostic breast mammogram and\u002For 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.\n* Pathologically proven diagnosis of invasive breast cancer, clinical stage I-III (cT1c-T4, N0-N3, M0).\n* Concurrent (neoadjuvant) systemic anti-cancer therapy is planned, including but not limited to endocrine therapy, chemotherapy, anti-HER2 therapy, and immunotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n* Bilateral breast cancer and\u002For multifocal, multicentric disease is allowed.\n* Appropriate pretreatment evaluations for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup: history\u002Fphysical examination, including breast exam (inspection and palpation of the breasts), within 30 days prior to study entry.\n* Patients with a prior history of breast cancer will be considered eligible.\n* Surgical candidacy as determined by the treating physician.\n* Patient must provide study-specific informed consent prior to study entry or have a legally authorized representative provide consent.\n\nExclusion Criteria:\n\n* American Joint Committee on Cancer (AJCC) clinical M1 breast cancer (i.e., with distant metastasis).\n* Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).\n* Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol treatment or providing informed consent.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":80},"Froedtert & the Medical College of Wisconsin","Milwaukee","Wisconsin","53226","United States",[75],{"name":76,"role":77,"phone":78,"email":79},"Lubna Chaudhary, MD, MS","CONTACT","414-805-4600","lchaudhary@mcw.edu",{"lat":81,"lon":82},43.0389,-87.90647,[84],{"name":85,"role":77,"phone":86,"phoneExt":87,"email":88},"Medical College of Wisconsin Cancer Center Clinical Trials Office","866-680-0505","8900","cccto@mcw.edu",[90],{"name":76,"affiliation":13,"role":91},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Breast Carcinoma",[],{"nct_id":4,"found":44,"summary":17,"prompt_version":17}]