[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sonya Reid\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27,28],"Invasive Mammary Carcinoma","Metastatic Breast Cancer","RECRUITING","2026-01-16",{"date":32,"type":33},"2026-01-20","ACTUAL",{"date":35,"type":33},"2023-09-28",{"date":37,"type":21},"2037-08-31",{"name":39,"class":40},"Sonya Reid","OTHER",3,""]