[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656533":3},{"organization":4,"outcomesModule":7,"designInfo":95,"detailedDescription":11,"studyPopulation":11,"armGroups":101,"interventions":111,"overallOfficials":121,"centralContacts":125,"locations":11,"responsibleParty":133,"collaborators":11,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":11,"enrollmentInfo":145,"targetDuration":11,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":11,"overallStatus":156,"whyStopped":11,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":11},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Participants who Have Discontinued Giredestrant for any Reason",null,"Month 12",[14,17,19,21,24,26,28,30,32,34,36,38,40,42,44,46,48,50,52,54,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93],{"measure":15,"description":11,"timeFrame":16},"Incidence and Severity of Adverse Events (AEs)","Up to approximately 5 years",{"measure":18,"description":11,"timeFrame":16},"Treatment Adherence, as Measured by Dose Intensity",{"measure":20,"description":11,"timeFrame":16},"Treatment Adherence, as Measured by Treatment Duration",{"measure":22,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)","At prespecified timepoints from Baseline until approximately 5 years",{"measure":25,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES",{"measure":27,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES",{"measure":29,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES",{"measure":31,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES",{"measure":33,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES",{"measure":35,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES",{"measure":37,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES",{"measure":39,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score",{"measure":41,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score",{"measure":43,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score",{"measure":45,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score",{"measure":47,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score",{"measure":49,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score",{"measure":51,"description":11,"timeFrame":23},"Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)",{"measure":53,"description":11,"timeFrame":23},"Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G",{"measure":55,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES","Month 6 and Month 12",{"measure":58,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES",{"measure":60,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES",{"measure":62,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES",{"measure":64,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score",{"measure":66,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score",{"measure":68,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Interference Composite Score",{"measure":70,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G",{"measure":72,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)",{"measure":74,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492",{"measure":76,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492",{"measure":78,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492",{"measure":80,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492",{"measure":82,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492",{"measure":84,"description":11,"timeFrame":23},"Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492",{"measure":86,"description":11,"timeFrame":23},"Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492",{"measure":88,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492",{"measure":90,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492",{"measure":92,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score",{"measure":94,"description":11,"timeFrame":56},"Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score",{"allocation":96,"interventionModel":97,"interventionModelDescription":11,"primaryPurpose":98,"observationalModel":11,"timePerspective":11,"maskingInfo":99},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":100,"maskingDescription":11,"whoMasked":11},"NONE",[102,108],{"label":103,"type":104,"description":105,"interventionNames":106},"Cohort A: Upfront Adjuvant Endocrine Therapy Population","EXPERIMENTAL","Participants will receive giredestrant.",[107],"Drug: Giredestrant",{"label":109,"type":104,"description":105,"interventionNames":110},"Cohort B: Switch Adjuvant Endocrine Therapy Population",[107],[112],{"type":113,"name":114,"description":115,"armGroupLabels":116,"otherNames":117},"DRUG","Giredestrant","Participants will receive giredestrant 30 mg orally once a day for up to 5 years.",[103,109],[118,119,120],"RO7197597","GDC-9545","RG6171",[122],{"name":123,"affiliation":5,"role":124},"Clinical Trials","STUDY_DIRECTOR",[126,131],{"name":127,"role":128,"phone":129,"phoneExt":11,"email":130},"Reference Study ID Number: BO46775 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":132,"role":128,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":134,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656533","phase-3-a-study-to-learn-how-well-participants-with-a-specific-type-of-early-breast-cancer-er-positive-her2-negative-tolerate-and-stay-on-treatment-with-giredestrant-and-how-they-feel-during-treatment-100656533",false,"NCT07827573","A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment","A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer","kalitERA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer\n* Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and\u002For sentinel lymph node biopsy)\n* Participants must have completed any prior adjuvant chemotherapy before enrollment, if given\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2\n* Adequate organ function\n* Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Diagnosis of inoperable locally advanced or Stage IV breast cancer\n* History of any prior (ipsilateral and\u002For contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)\n* Planned surgery during the study\n* Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents\n* Active cardiac disease or history of cardiac dysfunction","ALL","18 Years",{"count":146,"type":147},1500,"ESTIMATED","INTERVENTIONAL",[150],"PHASE3","The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant.\n\nThe study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4\u002F6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.",[153,154,155],"Early Breast Cancer","Estrogen Receptor-Positive Breast Cancer","HER2-Negative Breast Cancer","NOT_YET_RECRUITING","2026-09-15",{"date":159,"type":160},"2026-09-18","ACTUAL",{"date":162,"type":147},"2026-10-30",{"date":164,"type":147},"2032-11-30",{"name":5,"class":6}]