[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650426":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":37,"locations":28,"responsibleParty":45,"collaborators":28,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":28,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":28,"enrollmentInfo":56,"targetDuration":28,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":28,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":28},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Inavolisib + Fulvestrant + Palbociclib","EXPERIMENTAL","Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.",[13,14,15],"Drug: Inavolisib","Drug: Fulvestrant","Drug: Palbociclib",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Inavolisib","Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.",[9],[23],"RO7113755",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Fulvestrant","Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.",[9],null,{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Palbociclib","Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.",[9],[34],{"name":35,"affiliation":5,"role":36},"Clinical Trials","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":28,"email":42},"Reference Study ID Number: GO45322 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":44,"role":40,"phone":28,"phoneExt":28,"email":28},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":46,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100650426","phase-2-a-study-evaluating-the-safety-of-inavolisib-and-fulvestrant-with-or-without-palbociclib-in-participants-with-advanced-breast-cancer-abc-and-type-2-diabetes-100650426",false,"NCT07748208","A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes","A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes","Inclusion Criteria:\n\n* Type 2 diabetes with laboratory fasting blood glucose \\\u003C 185 milligrams per deciliter (mg\u002FdL) and HbA1c \\\u003C= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing\n* Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease\n* Confirmed diagnosis of HR+\u002FHER2- breast cancer\n* Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Metaplastic breast cancer\n* Any history of Type 1 diabetes\n* Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of active bowel inflammation or active inflammatory bowel disease","ALL","18 Years",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.",[64,65],"Breast Cancer","Diabetes Type II","NOT_YET_RECRUITING","2026-08-03",{"date":69,"type":70},"2026-08-05","ACTUAL",{"date":72,"type":58},"2026-09-01",{"date":74,"type":58},"2029-09-30",{"name":5,"class":6}]