[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"estrogen-receptor-positive-her2-negative-advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:estrogen-receptor-positive-her2-negative-advanced-breast-cancer":26},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100521142","phase-3-a-study-to-evaluate-efficacy-and-safety-of-giredestrant-compared-with-fulvestrant-plus-a-cdk46-inhibitor-in-participants-with-er-positive-her2-negative-advanced-breast-cancer-resistant-to-adjuvant-endocrine-therapy-pionera-breast-cancer-100521142",false,"NCT06065748","A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4\u002F6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4\u002F6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy","Inclusion Criteria:\n\n* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent\n* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)\n* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing\n* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \\>\u002F=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4\u002F6i is allowed (if relapse occurred \\>\u002F=12 months since completion).\n* No prior systemic anti-cancer therapy for advanced disease\n* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* For pre\u002Fperimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment\n\nExclusion Criteria:\n\n* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer\n* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n* Active cardiac disease or history of cardiac dysfunction\n* Clinically significant history of liver disease","ALL","18 Years",{"count":19,"type":20},1050,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4\u002F6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.",[26],"Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer",[28,29,30],"oral Selective Estrogen Receptor Degrader (SERD)","CDK4\u002F6 inhibitor (CDK4\u002F6i)","ESR1 mutation","RECRUITING","2026-08-03",{"date":34,"type":35},"2026-08-05","ACTUAL",{"date":37,"type":35},"2023-12-11",{"date":39,"type":20},"2029-02-12",{"name":41,"class":42},"Hoffmann-La Roche","INDUSTRY",352]