[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597107":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":11,"studyPopulation":11,"armGroups":37,"interventions":71,"overallOfficials":92,"centralContacts":96,"locations":104,"responsibleParty":403,"collaborators":11,"id":405,"slug":406,"hasResults":407,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":11,"eligibilityCriteria":411,"healthyVolunteers":407,"sex":412,"minAge":413,"maxAge":11,"enrollmentInfo":414,"targetDuration":11,"studyType":417,"phases":418,"briefSummary":420,"conditions":421,"keywords":11,"overallStatus":107,"whyStopped":11,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants with Adverse Events (AEs)",null,"From first dose up to 30 days after last dose (approximately 8 months)",[14,17,19,22,24,26,29],{"measure":15,"description":11,"timeFrame":16},"Percentage of Participants with Total Pathological Complete Response (pCR)","Up to approximately 8 months",{"measure":18,"description":11,"timeFrame":16},"Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1)",{"measure":20,"description":11,"timeFrame":21},"Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC)","Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days",{"measure":23,"description":11,"timeFrame":16},"Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire",{"measure":25,"description":11,"timeFrame":16},"Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire",{"measure":27,"description":11,"timeFrame":28},"Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE","Baseline, up to approximately 8 months",{"measure":30,"description":11,"timeFrame":28},"Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G GP5 Item",{"allocation":32,"interventionModel":33,"interventionModelDescription":11,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":11},"NONE",[38,46,50,54,58,63,67],{"label":39,"type":40,"description":41,"interventionNames":42},"Arm A","EXPERIMENTAL","Participants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,45],"Drug: Inavolisib","Drug: Ribociclib","Drug: Letrozole",{"label":47,"type":40,"description":48,"interventionNames":49},"Arm B","Participants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,45],{"label":51,"type":40,"description":52,"interventionNames":53},"Arm C","Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,45],{"label":55,"type":40,"description":56,"interventionNames":57},"Arm D (non-randomized)","Participants will receive inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,45],{"label":59,"type":40,"description":60,"interventionNames":61},"Arm E","Participants will receive inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,62],"Drug: Giredestrant",{"label":64,"type":40,"description":65,"interventionNames":66},"Arm F","Participants will receive a starting regimen of inavolisib and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,62],{"label":68,"type":40,"description":69,"interventionNames":70},"Arm G","Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and giredestrant PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + giredestrant as follows: inavolisib and giredestrant PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and giredestrant will be administered PO QD on days 1-21 (each cycle=21 days).",[43,44,62],[72,80,84,88],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"DRUG","Inavolisib","Inavolisib will be administered as per the schedule specified in the arms",[39,47,51,55,59,64,68],[78,79],"GDC-0077","RO7113755",{"type":73,"name":81,"description":82,"armGroupLabels":83,"otherNames":11},"Ribociclib","Ribociclib will be administered as per the schedule specified in the arms",[39,47,51,55,59,64,68],{"type":73,"name":85,"description":86,"armGroupLabels":87,"otherNames":11},"Letrozole","Letrozole will be administered as per the schedule specified in the arms",[39,47,51,55],{"type":73,"name":89,"description":90,"armGroupLabels":91,"otherNames":11},"Giredestrant","Giredestrant will be administered as per the schedule specified in the arms",[59,64,68],[93],{"name":94,"affiliation":5,"role":95},"Clinical Trials","STUDY_DIRECTOR",[97,102],{"name":98,"role":99,"phone":100,"phoneExt":11,"email":101},"Reference Study ID Number: BO45853 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":103,"role":99,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[105,119,128,138,148,159,165,169,181,191,201,210,222,232,242,248,254,265,271,280,289,298,307,316,326,332,338,344,355,361,370,376,385,394],{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":11},"Los Angeles Cancer Network","RECRUITING","Los Angeles","California","90017-4803","United States","US",{"type":114,"coordinates":115},"Point",[116,117],-118.24368,34.05223,{"lat":117,"lon":116},{"facility":120,"status":107,"city":121,"state":109,"zip":122,"country":111,"countryCode":112,"cosmosGeoPoint":123,"geoPoint":127,"contacts":11},"Community Clinical Trials","Orange","92868",{"type":114,"coordinates":124},[125,126],-117.85311,33.78779,{"lat":126,"lon":125},{"facility":129,"status":107,"city":130,"state":131,"zip":132,"country":111,"countryCode":112,"cosmosGeoPoint":133,"geoPoint":137,"contacts":11},"West Cancer Center","Germantown","Tennessee","38138",{"type":114,"coordinates":134},[135,136],-89.81009,35.08676,{"lat":136,"lon":135},{"facility":139,"status":107,"city":140,"state":141,"zip":142,"country":111,"countryCode":112,"cosmosGeoPoint":143,"geoPoint":147,"contacts":11},"West Virginia University","Morgantown","West Virginia","26506",{"type":114,"coordinates":144},[145,146],-79.9559,39.62953,{"lat":146,"lon":145},{"facility":149,"status":107,"city":150,"state":11,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"Hospital Aleman de Buenos Aires","Buenos Aires","C1118AAT","Argentina","AR",{"type":114,"coordinates":155},[156,157],-58.37723,-34.61315,{"lat":157,"lon":156},{"facility":160,"status":107,"city":150,"state":11,"zip":161,"country":152,"countryCode":153,"cosmosGeoPoint":162,"geoPoint":164,"contacts":11},"Centro Médico Fleischer","C1414DRK",{"type":114,"coordinates":163},[156,157],{"lat":157,"lon":156},{"facility":166,"status":107,"city":167,"state":11,"zip":168,"country":152,"countryCode":153,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Centro Oncologico Korben","Ciudad Autonoma Buenos Aires","C1426AGE",{"facility":170,"status":107,"city":171,"state":172,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":11},"Hospital Araujo Jorge","Goiânia","Goiás","74605-070","Brazil","BR",{"type":114,"coordinates":177},[178,179],-49.25389,-16.67861,{"lat":179,"lon":178},{"facility":182,"status":107,"city":183,"state":184,"zip":185,"country":174,"countryCode":175,"cosmosGeoPoint":186,"geoPoint":190,"contacts":11},"Hospital do Cancer de Pernambuco - HCP","Recife","Pernambuco","50040-000",{"type":114,"coordinates":187},[188,189],-34.88111,-8.05389,{"lat":189,"lon":188},{"facility":192,"status":107,"city":193,"state":194,"zip":195,"country":174,"countryCode":175,"cosmosGeoPoint":196,"geoPoint":200,"contacts":11},"Irmandade Da Santa Casa de Misericordia de Porto Alegre","Porto Alegre","Rio Grande do Sul","90035-074",{"type":114,"coordinates":197},[198,199],-51.23019,-30.03283,{"lat":199,"lon":198},{"facility":202,"status":107,"city":203,"state":203,"zip":204,"country":174,"countryCode":175,"cosmosGeoPoint":205,"geoPoint":209,"contacts":11},"Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda","São Paulo","01317-000",{"type":114,"coordinates":206},[207,208],-46.63611,-23.5475,{"lat":208,"lon":207},{"facility":211,"status":107,"city":212,"state":213,"zip":214,"country":215,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":11},"BC Cancer - Vancouver","Vancouver","British Columbia","V5Z 4E6","Canada","CA",{"type":114,"coordinates":218},[219,220],-123.11934,49.24966,{"lat":220,"lon":219},{"facility":223,"status":107,"city":224,"state":225,"zip":226,"country":215,"countryCode":216,"cosmosGeoPoint":227,"geoPoint":231,"contacts":11},"Sunnybrook Odette Cancer Centre","Toronto","Ontario","M4N 3M5",{"type":114,"coordinates":228},[229,230],-79.39864,43.70643,{"lat":230,"lon":229},{"facility":233,"status":107,"city":234,"state":235,"zip":236,"country":215,"countryCode":216,"cosmosGeoPoint":237,"geoPoint":241,"contacts":11},"Centre Hospitalier de l'Universite de Montreal (CHUM)","Montreal","Quebec","H2X 0C2",{"type":114,"coordinates":238},[239,240],-73.58781,45.50884,{"lat":240,"lon":239},{"facility":243,"status":107,"city":234,"state":235,"zip":244,"country":215,"countryCode":216,"cosmosGeoPoint":245,"geoPoint":247,"contacts":11},"Jewish General Hospital","H3T1E2",{"type":114,"coordinates":246},[239,240],{"lat":240,"lon":239},{"facility":249,"status":107,"city":234,"state":235,"zip":250,"country":215,"countryCode":216,"cosmosGeoPoint":251,"geoPoint":253,"contacts":11},"McGill University Health Center","H4A 3J1",{"type":114,"coordinates":252},[239,240],{"lat":240,"lon":239},{"facility":255,"status":107,"city":256,"state":11,"zip":257,"country":258,"countryCode":259,"cosmosGeoPoint":260,"geoPoint":264,"contacts":11},"Das Brustzentrum","Berlin","12623","Germany","DE",{"type":114,"coordinates":261},[262,263],13.41053,52.52437,{"lat":263,"lon":262},{"facility":266,"status":107,"city":256,"state":11,"zip":267,"country":258,"countryCode":259,"cosmosGeoPoint":268,"geoPoint":270,"contacts":11},"HELIOS Klinikum Berlin-Buch","13125",{"type":114,"coordinates":269},[262,263],{"lat":263,"lon":262},{"facility":272,"status":107,"city":273,"state":11,"zip":274,"country":258,"countryCode":259,"cosmosGeoPoint":275,"geoPoint":279,"contacts":11},"Universitätsklinikum \"Carl Gustav Carus\" der Technischen Universität Dresden","Dresden","01307",{"type":114,"coordinates":276},[277,278],13.73832,51.05089,{"lat":278,"lon":277},{"facility":281,"status":107,"city":282,"state":11,"zip":283,"country":258,"countryCode":259,"cosmosGeoPoint":284,"geoPoint":288,"contacts":11},"Kliniken Essen-Mitte","Essen","45136",{"type":114,"coordinates":285},[286,287],7.01228,51.45657,{"lat":287,"lon":286},{"facility":290,"status":107,"city":291,"state":11,"zip":292,"country":258,"countryCode":259,"cosmosGeoPoint":293,"geoPoint":297,"contacts":11},"Universitätsklinikum Heidelberg","Heidelberg","69120",{"type":114,"coordinates":294},[295,296],8.69079,49.40768,{"lat":296,"lon":295},{"facility":299,"status":107,"city":300,"state":11,"zip":301,"country":258,"countryCode":259,"cosmosGeoPoint":302,"geoPoint":306,"contacts":11},"St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise","Paderborn","33098",{"type":114,"coordinates":303},[304,305],8.75439,51.71905,{"lat":305,"lon":304},{"facility":308,"status":107,"city":309,"state":11,"zip":310,"country":258,"countryCode":259,"cosmosGeoPoint":311,"geoPoint":315,"contacts":11},"HELIOS Klinikum Schwerin","Schwerin","19055",{"type":114,"coordinates":312},[313,314],11.41316,53.62937,{"lat":314,"lon":313},{"facility":317,"status":107,"city":318,"state":11,"zip":319,"country":320,"countryCode":11,"cosmosGeoPoint":321,"geoPoint":325,"contacts":11},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":114,"coordinates":322},[323,324],126.9784,37.566,{"lat":324,"lon":323},{"facility":327,"status":107,"city":318,"state":11,"zip":328,"country":320,"countryCode":11,"cosmosGeoPoint":329,"geoPoint":331,"contacts":11},"Severance Hospital, Yonsei University Health System","03722",{"type":114,"coordinates":330},[323,324],{"lat":324,"lon":323},{"facility":333,"status":107,"city":318,"state":11,"zip":334,"country":320,"countryCode":11,"cosmosGeoPoint":335,"geoPoint":337,"contacts":11},"Asan Medical Center.","05505",{"type":114,"coordinates":336},[323,324],{"lat":324,"lon":323},{"facility":339,"status":107,"city":318,"state":11,"zip":340,"country":320,"countryCode":11,"cosmosGeoPoint":341,"geoPoint":343,"contacts":11},"Samsung Medical Center","06351",{"type":114,"coordinates":342},[323,324],{"lat":324,"lon":323},{"facility":345,"status":107,"city":346,"state":11,"zip":347,"country":348,"countryCode":349,"cosmosGeoPoint":350,"geoPoint":354,"contacts":11},"Vall d'Hebron Institute of Oncology (VHIO), Barcelona","Barcelona","08035","Spain","ES",{"type":114,"coordinates":351},[352,353],2.15899,41.38879,{"lat":353,"lon":352},{"facility":356,"status":107,"city":346,"state":11,"zip":357,"country":348,"countryCode":349,"cosmosGeoPoint":358,"geoPoint":360,"contacts":11},"Hospital Clinic Barcelona","08036",{"type":114,"coordinates":359},[352,353],{"lat":353,"lon":352},{"facility":362,"status":107,"city":363,"state":11,"zip":364,"country":348,"countryCode":349,"cosmosGeoPoint":365,"geoPoint":369,"contacts":11},"Hospital General Universitario Gregorio Marañon","Madrid","28007",{"type":114,"coordinates":366},[367,368],-3.70256,40.4165,{"lat":368,"lon":367},{"facility":371,"status":107,"city":363,"state":11,"zip":372,"country":348,"countryCode":349,"cosmosGeoPoint":373,"geoPoint":375,"contacts":11},"Hospital Universitario 12 de Octubre","28041",{"type":114,"coordinates":374},[367,368],{"lat":368,"lon":367},{"facility":377,"status":107,"city":378,"state":11,"zip":379,"country":348,"countryCode":349,"cosmosGeoPoint":380,"geoPoint":384,"contacts":11},"Hospital Clinico Universitario de Salamanca","Salamanca","37007",{"type":114,"coordinates":381},[382,383],-5.66388,40.96882,{"lat":383,"lon":382},{"facility":386,"status":107,"city":387,"state":11,"zip":388,"country":348,"countryCode":349,"cosmosGeoPoint":389,"geoPoint":393,"contacts":11},"Hospital Universitario Virgen Macarena","Seville","41009",{"type":114,"coordinates":390},[391,392],-5.97317,37.38283,{"lat":392,"lon":391},{"facility":395,"status":107,"city":396,"state":11,"zip":397,"country":348,"countryCode":349,"cosmosGeoPoint":398,"geoPoint":402,"contacts":11},"Hospital Clínico Universitario de Valencia","Valencia","46010",{"type":114,"coordinates":399},[400,401],-0.37966,39.47391,{"lat":401,"lon":400},{"type":404,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100597107","phase-2-a-study-to-test-inavolisib-treatments-in-participants-with-early-stage-pik3ca-mutated-breast-cancer-100597107",false,"NCT07054190","A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer","A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification\n* Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy\n* Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)\n* Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines\n* Documented HER2-negative tumor in accordance with current ASCO\u002FCAP guidelines\n* Documented Ki-67 score \\>=5% as per local assessment\n* Confirmed PIK3CA mutation\n\nExclusion Criteria:\n\n* Stage IV (metastatic) BC\n* Inflammatory BC (cT4d)\n* Bilateral invasive BC\n* History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast\n* Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and\u002For axillary lymph nodes, and sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes","FEMALE","18 Years",{"count":415,"type":416},120,"ESTIMATED","INTERVENTIONAL",[419],"PHASE2","This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).",[422],"Breast Cancer","2026-08-27",{"date":425,"type":426},"2026-08-31","ACTUAL",{"date":428,"type":426},"2025-09-09",{"date":430,"type":416},"2027-09-28",{"name":5,"class":6},34]