[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640290":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":115,"centralContacts":67,"locations":119,"responsibleParty":151,"collaborators":153,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":67,"eligibilityCriteria":163,"healthyVolunteers":159,"sex":164,"minAge":165,"maxAge":67,"enrollmentInfo":166,"targetDuration":67,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":67,"overallStatus":179,"whyStopped":67,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (Biology guided therapy report)","EXPERIMENTAL","Patients have their tumor tissue analyzed. Their physician receives a report based on their tumor biology consisting of their predicted ongoing response to endocrine therapy, predicted ongoing response to endocrine therapy plus PIK3CA mutation or ESR1 mutation or HER2 mutation or mTOR sensitivity\u002Fresistance. The report includes treatment recommendations and the results of the specific tests completed on the tumor tissue. Physicians then determine a treatment regimen for the patient that may or may not include the treatment recommended in the report. Patients undergo blood sample collection and CT scan or MRI and\u002For bone scan and\u002For PET scan throughout the study. Patients may undergo tumor biopsy during screening and may optionally undergo at progression.",[13,14,15,16,17,18,19,20,21],"Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Procedure: Bone Scan","Procedure: Computed Tomography","Other: Electronic Health Record Review","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography","Other: Treatment Planning","Other: Treatment Regimen",[23,32,40,46,63,68,88,100,104],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Biopsy Procedure","Undergo tumor biopsy",[9],[29,30,31],"Biopsy","BIOPSY_TYPE","Bx",{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Biospecimen Collection","Undergo blood sample collection",[9],[37,38,39],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":24,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Bone Scan","Undergo bone scan",[9],[45],"Bone Scintigraphy",{"type":24,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Computed Tomography","Undergo CT scan",[9],[51,52,53,54,55,56,57,58,59,60,61,62],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Electronic Health Record Review","Ancillary studies",[9],null,{"type":24,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Magnetic Resonance Imaging","Undergo MRI",[9],[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":24,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Positron Emission Tomography","Undergo PET scan",[9],[93,94,95,96,97,98,99],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":6,"name":101,"description":102,"armGroupLabels":103,"otherNames":67},"Treatment Planning","Receive tumor biology report with predicted ongoing response",[9],{"type":6,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Treatment Regimen","Receive treatment recommendations",[9],[109,110,111,112,113,114],"Regimen","regimen or line of therapy","Regimen\u002FTreatment Period\u002FVaccination Regimen","regimen_or_line_of_therapy","Treatment Protocol","Treatment Schedule",[116],{"name":117,"affiliation":5,"role":118},"Irene M Kang","PRINCIPAL_INVESTIGATOR",[120,139],{"facility":5,"status":67,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Duarte","California","91010","United States","US",{"type":127,"coordinates":128},"Point",[129,130],-117.97729,34.13945,{"lat":130,"lon":129},[133,138],{"name":134,"role":135,"phone":136,"phoneExt":67,"email":137},"Irene M. Kang","CONTACT","844-756-2047","ikang@coh.org",{"name":134,"role":118,"phone":67,"phoneExt":67,"email":67},{"facility":140,"status":67,"city":141,"state":122,"zip":142,"country":124,"countryCode":125,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"City of Hope at Irvine Lennar","Irvine","92618",{"type":127,"coordinates":144},[145,146],-117.82311,33.66946,{"lat":146,"lon":145},[149,150],{"name":134,"role":135,"phone":136,"phoneExt":67,"email":137},{"name":134,"role":118,"phone":67,"phoneExt":67,"email":67},{"type":152,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR",[154],{"name":155,"class":156},"National Cancer Institute (NCI)","NIH","100640290","phase-1-biology-guided-therapy-recommendations-for-treatment-determination-of-hormone-receptor-positive-advanced-unresectable-or-metastatic-breast-cancer-endorse-trial-100640290",false,"NCT07590583","Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial","Pilot Study: Evaluation of Novel Data-Driven Outcomes Via Response-Guided Systems Medicine in Hormone Receptor-Positive Advanced Breast Cancer (ENDORSE)","Inclusion Criteria:\n\n* Participant must speak English\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Patients must have histologically confirmed, unresectable or metastatic hormone receptor positive, HER2 breast cancer. Hormone receptor positive is defined as estrogen receptor \\>= 10% and\u002For progesterone receptor \\>= 10%. Her2 negative per American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines\n* Patient must have disease progression during or after prior endocrine therapy meeting one of the following criteria:\n\n  * Disease progression on 1st line endocrine therapy for advanced\u002Fmetastatic breast cancer.\n  * Disease progression on or within 2 years of completion of treatment with a CDK4\u002F6i in the adjuvant setting for early- stage breast cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Patient must have at least one lesion amenable to percutaneous core\n* Clinically appropriate for biopsy\n\nExclusion Criteria:\n\n* Prior treatment in the metastatic setting with capecitabine, phosphoinositide 3 kinase (PI3K) inhibitor, mechanistic target of rapamycin (mTOR) inhibitor, protein kinase B (Akt) inhibitor, selective estrogen receptor degrader (SERD), or HER2-targeted therapy, including neratinib\n* Known or untreated, or active, brain or leptomeningeal metastases that are deemed inappropriate to pursue therapy guided by systems medicine approach. Enrolled patients may receive radiation or other loco regional therapy prior to initiating systemic therapy on study. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors not requiring active therapy\n* Life expectancy \\\u003C 1 year\n* Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures","ALL","18 Years",{"count":167,"type":168},20,"ESTIMATED","INTERVENTIONAL",[171],"PHASE1","This clinical trial tests the feasibility and utility of a biology guided therapy recommendations report to aid in determining treatment of hormone receptor positive breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). The biology guided therapy recommendations report is developed from testing a patients tumor tissue when they have progression to see what medications may work best and what medications the cancer may be resistant to based on their tumor biology. Patients and their doctor then receive that report with the suggested treatments. Receiving a biology guided therapy recommendations report may be a feasible and useable way to aid in treatment determination for hormone receptor positive advanced, unresectable or metastatic breast cancer.",[174,175,176,177,178],"Advanced Hormone Receptor-Positive Breast Carcinoma","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Hormone Receptor-Positive Breast Carcinoma","Unresectable Hormone Receptor-Positive Breast Carcinoma","NOT_YET_RECRUITING","2026-05-12",{"date":182,"type":183},"2026-05-15","ACTUAL",{"date":185,"type":168},"2026-12-19",{"date":187,"type":168},"2027-12-02",{"name":5,"class":6},2]