[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492563":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":92,"collaborators":96,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":11,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Vanderbilt-Ingram Cancer Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes","ACTIVE_COMPARATOR",null,[13,14],"Other: Endocrine-therapy","Other: MammoPrint ® and BluePrint assays",{"label":16,"type":17,"description":11,"interventionNames":18},"Capecitabine_Non-Luminal A subtypes","EXPERIMENTAL",[19,14],"Drug: Capecitabine",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Capecitabine","2000 mg taken by mouth twice daily for 7 days on, 7 days off",[16],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Endocrine-therapy","Endocrine therapy administered",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"MammoPrint ® and BluePrint assays","Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays",[16,9],[35],{"name":36,"affiliation":37,"role":38},"Sonya Reid, MD","Vanderbilt University\u002FIngram Cancer Center","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Vanderbilt-Ingram Services for Timely Access","CONTACT","800-811-8480","cip@vumc.org",[46,65,78],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of Alabama Birmingham","RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-86.80249,33.52066,{"lat":58,"lon":57},[61,63],{"name":62,"role":42,"phone":11,"phoneExt":11,"email":11},"Kyndall Thomas",{"name":64,"role":38,"phone":11,"phoneExt":11,"email":11},"Nusrat Jahan",{"facility":37,"status":48,"city":66,"state":67,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Nashville","Tennessee","37232",{"type":55,"coordinates":70},[71,72],-86.78444,36.16589,{"lat":72,"lon":71},[75,77],{"name":76,"role":42,"phone":43,"phoneExt":11,"email":44},"Vanderbilt-Ingram Service for Timely Access",{"name":36,"role":38,"phone":11,"phoneExt":11,"email":11},{"facility":79,"status":48,"city":80,"state":81,"zip":82,"country":52,"countryCode":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":55,"coordinates":84},[85,86],-96.80667,32.78306,{"lat":86,"lon":85},[89,90],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":11},{"name":91,"role":38,"phone":11,"phoneExt":11,"email":11},"Heather McArthur, MD, PhD",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Sonya Reid","Assistant Professor of Medicine",[97,100],{"name":98,"class":99},"Agendia","INDUSTRY",{"name":101,"class":6},"Susan G. Komen Breast Cancer Foundation","100492563","phase-2-gene-signatures-to-guide-hrmbc-therapy-in-a-diverse-cohort-100492563",false,"NCT05693766","Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort","Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)","INSIGHT","Inclusion Criteria:\n\n* Signed and dated written informed consent.\n* Subjects ≥ 18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:\n\n  * ER (\\>\u002F=1%) and\u002For PR (\\>\u002F= 1%) by IHC and HER2 negative (by IHC or FISH)\n* Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator\u002F downregulator (SERM; SERD) + a CDK4\u002F6 inhibitor.\n* Prior radiation permitted (if completed at least 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)\n* Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids\n* Evaluable disease (measurable or non-measurable)\n\n  * Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)\n  * Patients with bone only disease allowed if possible to evaluate on radiological exams (eg.bone scan, PET\u002FCT, CT, MRI) even if lesions are non-measurable according to RECIST1.1.\n* Adequate organ function including:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Hemoglobin ≥ 8\u002Fg\u002FdL (may have been transfused)\n  * Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)\n  * Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL\u002Fmin as calculated using the Cockcroft-Gault (CG) equation\n* For randomized patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests\n\nExclusion Criteria:\n\n* Prior chemotherapy in the metastatic setting\n* Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).\n* Persisting symptoms related to prior therapy that has not reduced to Grade 1 \\[National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0\\]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable\n* Pregnant or breastfeeding females.","ALL","18 Years",{"count":113,"type":114},64,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)",[120,121],"Invasive Mammary Carcinoma","Metastatic Breast Cancer","2026-01-16",{"date":124,"type":125},"2026-01-20","ACTUAL",{"date":127,"type":125},"2023-09-28",{"date":129,"type":114},"2037-08-31",{"name":94,"class":6},3]