[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555957":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":119,"collaborators":123,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":32,"enrollmentInfo":136,"targetDuration":32,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide","EXPERIMENTAL","Tirzepatide will be administered subcutaneously in the stomach, upper arm, or thigh, rotating injection sites with each dose. Administer once weekly at any time of day, with or without meals. Start with an initial dosage of 2.5 mg. After 4 weeks, increase to 5 mg weekly. Further increases may be made in 2.5 mg increments after at least 4 weeks on the current dose, aiming for a target of 15 mg (i.e., 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg). Consider treatment tolerability when selecting the maintenance dose. If not tolerated, consider the next lower maintenance dose. Recommended maintenance doses are 5 mg, 10 mg, or 15 mg, with 5 mg as the lowest evaluable dose. The 2.5 mg dose is not a maintenance dose. The maximum allowed dosage is 15 mg once weekly.",[13],"Drug: Tirzepatide",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The intervention aims to assess the feasibility, safety, and efficacy of tirzepatide for weight loss in patients with early-stage hormone receptor-positive, HER2-negative breast cancer, potentially improving treatment outcomes and overall health.",[9],[20,21,22],"LY3298176 (development code name)","Mounjaro (brand name in certain regions)","Zepbound (brand name in certain regions)",[24],{"name":25,"affiliation":26,"role":27},"Coral Omene, MD., PhD","Rutgers Cancer Institute","PRINCIPAL_INVESTIGATOR",[29],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","732-235-3374",null,"co273@cinj.rutgers.edu",[35,52,64,75,86,97,108],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Trinitas Comprehensive Cancer Center","RECRUITING","Elizabeth","New Jersey","07202","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.2107,40.66399,{"lat":47,"lon":46},[50],{"name":51,"role":30,"phone":31,"phoneExt":32,"email":33},"Coral Omene, MD.,PhD",{"facility":53,"status":54,"city":55,"state":39,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton","NOT_YET_RECRUITING","Hamilton","08690",{"type":44,"coordinates":58},[59,60],-74.08125,40.20706,{"lat":60,"lon":59},[63],{"name":51,"role":30,"phone":31,"phoneExt":32,"email":33},{"facility":65,"status":37,"city":66,"state":39,"zip":67,"country":41,"countryCode":42,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"RWJBarnabas Health - Cooperman Barnabas, Livingston","Livingston","07039",{"type":44,"coordinates":69},[70,71],-74.31487,40.79593,{"lat":71,"lon":70},[74],{"name":51,"role":30,"phone":31,"phoneExt":32,"email":33},{"facility":76,"status":37,"city":77,"state":39,"zip":78,"country":41,"countryCode":42,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"RWJBarnabas Health - Monmouth Medical Center","Long Branch","07740",{"type":44,"coordinates":80},[81,82],-73.99236,40.30428,{"lat":82,"lon":81},[85],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},{"facility":26,"status":37,"city":87,"state":39,"zip":88,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"New Brunswick","08901",{"type":44,"coordinates":90},[91,92],-74.45182,40.48622,{"lat":92,"lon":91},[95],{"name":96,"role":30,"phone":31,"phoneExt":32,"email":33},"Coral Omene,, MD.PhD",{"facility":98,"status":37,"city":99,"state":39,"zip":100,"country":41,"countryCode":42,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"RWJBarnabas Health - Newark Beth Israel Medical Center","Newark","07112",{"type":44,"coordinates":102},[103,104],-74.17237,40.73566,{"lat":104,"lon":103},[107],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},{"facility":109,"status":37,"city":110,"state":39,"zip":111,"country":41,"countryCode":42,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset","Somerville","08876",{"type":44,"coordinates":113},[114,115],-74.60988,40.57427,{"lat":115,"lon":114},[118],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},{"type":27,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":122,"oldNameTitle":32,"oldOrganization":32},"Coral Omene","Program Director, Breast Cancer Disparities Research; Associate Professor of Medicine","Rutgers Cancer Institute of New Jersey",[124],{"name":125,"class":6},"Ludwig Institute for Cancer Research","100555957","phase-2-tirzepatide-for-weight-loss-intervention-in-early-stage-hormone-receptor-positiveher2-negative-breast-cancer-100555957",false,"NCT06518837","Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive\u002FHER2 Negative Breast Cancer","FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive\u002FHER2 Negative Breast Cancer","FITWISE","Inclusion Criteria:\n\n* Consent: Be willing and able to provide written informed consent for the trial.\n* Age: Male or Female patients aged 18 years or older.\n* Breast Cancer Diagnosis: Have hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer previously diagnosed by biopsy. HR status is defined as estrogen receptor (ER) \\>10% and\u002For progesterone receptor (PR) \\>10%; HER2 status is defined as immunohistochemistry (IHC) 0 or 1+ or IHC 2+, fluorescence in situ hybridization (FISH) negative.\n* Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or III hormone receptor-positive breast cancer.\n* Definitive Treatment: Have had definitive treatment with curative intent for breast cancer, including surgery, chemotherapy, and radiotherapy as indicated.\n* Body Mass Index (BMI): Have a BMI of 30 kg\u002Fm² or more, or a BMI of 27 kg\u002Fm² or more with one weight-related complication (e.g., hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).\n* Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% or greater, or greater than the institution's lower limit of normal (LLN), as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.\n* Organ Function: Demonstrate adequate organ function in screening labs.\n* Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumor blocks or unstained slides.\n\nExclusion Criteria:\n\n* Other Clinical Studies: Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.\n* Stage IV Breast Cancer: Have stage IV, metastatic breast cancer.\n* Cancer Type: Have HER2-positive or triple-negative breast cancer.\n* Active Malignancy: Have a concomitant active malignancy.\n* Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2.\n* Body Mass Index: Have a BMI of less than 27 kg\u002Fm².\n* Type 1 Diabetes Mellitus: Have type 1 diabetes mellitus.\n* Gastric Emptying Abnormality: Have a known clinically important gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically took drugs that directly affect gastrointestinal motility.","ALL","18 Years",{"count":137,"type":138},40,"ESTIMATED","INTERVENTIONAL",[141],"PHASE2","This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+\u002FHer2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).",[144,145],"Hormone Receptor-Positive Breast Cancer","HER2-Negative Breast Cancer",[147,148,149,150,151,152,153,154,9,155,156,157],"Weight Loss","Body Weight Reduction","Feasibility of Weight Loss Intervention","invasive Disease-Free Survival (IDFS)","Body Mass Index (BMI)","Body Fat Distribution","Metabolic Markers","Circulating Tumor DNA (ctDNA)","GIP and GLP-1 dual agonist","Black patients","distant relapse-free survival (DRFS)","2026-01-17",{"date":160,"type":161},"2026-01-21","ACTUAL",{"date":163,"type":161},"2024-10-30",{"date":165,"type":138},"2027-09-30",{"name":5,"class":6},7]