[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659675":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":11,"studyPopulation":11,"armGroups":26,"interventions":44,"overallOfficials":68,"centralContacts":72,"locations":11,"responsibleParty":80,"collaborators":11,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":11,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":104,"whyStopped":11,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":11},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and Severity of Adverse Events (AEs)",null,"Approximately 30 months",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Plasma Concentration of GDC-4198",{"measure":17,"description":11,"timeFrame":12},"Objective Response Rate (ORR)",{"measure":19,"description":11,"timeFrame":12},"Clinical Benefit Rate (CBR)",{"allocation":21,"interventionModel":22,"interventionModelDescription":11,"primaryPurpose":23,"observationalModel":11,"timePerspective":11,"maskingInfo":24},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":25,"maskingDescription":11,"whoMasked":11},"NONE",[27,34,39],{"label":28,"type":29,"description":30,"interventionNames":31},"GDC-4198 with fulvestrant","EXPERIMENTAL","During safety run-in stage, participants will receive GDC-4198, higher dose in combination with fulvestrant, as per a pre-defined dosing regimen during Cycle 1 (1 cycle=28 days).\n\nDuring expansion stage, participants will receive GDC-4198, either lower or higher dose in combination with fulvestrant, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression.",[32,33],"Drug: GDC-4198","Drug: Fulvestrant",{"label":35,"type":29,"description":36,"interventionNames":37},"GDC-4198 with letrozole","During expansion stage, participants will receive GDC-4198, either lower or higher dose in combination with letrozole, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression.",[32,38],"Drug: Letrozole",{"label":40,"type":29,"description":41,"interventionNames":42},"GDC-4198 with giredestrant","During expansion stage, participants will receive GDC-4198, either lower or higher dose in combination with giredestrant, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression.",[32,43],"Drug: Giredestrant",[45,53,57,61],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","GDC-4198","Participants will receive GDC-4198 as per the schedule described in the protocol.",[28,40,35],[51,52],"RGT-419B","RO7840734",{"type":46,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"Fulvestrant","Participants will receive fulvestrant as per the schedule described in the protocol.",[28],{"type":46,"name":58,"description":59,"armGroupLabels":60,"otherNames":11},"Letrozole","Participants will receive letrozole as per the schedule described in the protocol.",[35],{"type":46,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Giredestrant","Participants will receive giredestrant as per the schedule described in the protocol.",[40],[66,67],"GDC-9545","RO7197597",[69],{"name":70,"affiliation":5,"role":71},"Clinical Trials","STUDY_DIRECTOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":11,"email":77},"Reference Study ID Number: GO46022 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":79,"role":75,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":81,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659675","phase-1-a-study-to-evaluate-the-effects-of-gdc-4198-in-combination-with-letrozole-fulvestrant-or-giredestrant-in-participants-with-locally-advanced-or-metastatic-hormone-receptor-positive-her2-negatve-breast-cancer-100659675",false,"NCT07867262","A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer","A Phase Ib, Multicenter, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Are Sensitive or Resistant to Endocrine Therapy","FrontROSE","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and HER2-negative disease.\n* Disease documented HER2-negative tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines or documented ER-positive tumor according to ASCO\u002FCAP guidelines.\n* Measurable and\u002For non-measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (including bone-only disease).\n* For females \\\u003C= 60 years of age who are not in a postmenopausal state and males: initiation of treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy prior to initiation of study treatment according to clinical practice for the selected agent (preferably at least 14 days prior to initiation of study treatment), and agreement to continue LHRH agonist therapy for the duration of the study. LHRH agonist therapy may be discontinued in women \\> 60 years of age.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy \\>= 6 months.\n* Participants with Endocrine therapy (ET)-resistant disease and ET-sensitive disease as defined in the protocol.\n\nExclusion Criteria:\n\n* Advanced, symptomatic, visceral spread at the time of study entry that is at risk of life-threating complications and for which treatment with cytotoxic chemotherapy is considered appropriate per local treatment guidelines.\n* Symptomatic, untreated, or actively progressing CNS metastases.\n* History of systemic anti-cancer therapy for unresectable locally advanced breast cancer or metastatic breast cancer.\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption.\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.\n* Known allergy or hypersensitivity to any component of the study treatments.","ALL","18 Years",{"count":93,"type":94},165,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","The study will evaluate the safety, pharmacokinetics, and preliminary activity of GDC-4198 when given in combination with endocrine therapy (ET) (letrozole, fulvestrant, or giredestrant) as first-line treatment to participants with locally advanced or metastatic Hormone receptor (HR)-positive, Human epidermal growth factor receptor-2 (HER2)-negative breast cancer",[100],"Advanced or Metastatic Breast Cancer",[102,103],"HR+ positive","HER2 negative breast cancer","NOT_YET_RECRUITING","2026-10-05",{"date":107,"type":108},"2026-10-09","ACTUAL",{"date":110,"type":94},"2026-12-15",{"date":112,"type":94},"2030-08-15",{"name":5,"class":6}]