[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07405801":3,"trial-entities:NCT07405801":490,"trial-summary:NCT07405801":495},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":52,"sex":72,"minimum_age":73,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":89,"locations":92,"central_contacts":473,"overall_officials":481,"references":485,"see_also_links":486},"NCT07405801","CO46274","A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer","A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation","RECRUITING","2030-02-26","2026-08","2026-08-11","2026-04-07","Hoffmann-La Roche","INDUSTRY",false,"A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).",null,[19],"Breast Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},80,"ESTIMATED",[29,35,40,44],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Inavolisib","Inavolisib will be administered as per the schedule mentioned in the protocol.",[34],"Inavolisib + Ribociclib + Fulvestrant",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Ribociclib","Ribociclib will be administered as per the schedule mentioned in the protocol.",[34,39],"Placebo + Ribociclib + Fulvestrant",{"type":30,"name":41,"description":42,"armGroupLabels":43},"Fulvestrant","Fulvestrant will be administered as per the schedule mentioned in the protocol.",[34,39],{"type":30,"name":45,"description":46,"armGroupLabels":47},"Placebo","Placebo will be administered as per the schedule mentioned in the protocol.",[39],[49],{"measure":50,"timeFrame":51},"Percentage of Participants With Confirmed Objective Response (cORR)","Up to approximately 2 years",[53,55,57,59,61,63,65,67,70],{"measure":54,"timeFrame":51},"Progression-Free Survival (PFS)",{"measure":56,"timeFrame":51},"Overall Survival (OS)",{"measure":58,"timeFrame":51},"Duration of Response (DOR)",{"measure":60,"timeFrame":51},"Percentage of Participants with Clinical Benefit (CBR)",{"measure":62,"timeFrame":51},"Percentage of Participants with Adverse Events (AEs)",{"measure":64,"timeFrame":51},"Number of Participants Reporting Presence, Frequency, Severity, and\u002For Degree of Interference With Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)",{"measure":66,"timeFrame":51},"Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G)",{"measure":68,"timeFrame":69},"Change From Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE","Baseline, Up to approximately 2 years",{"measure":71,"timeFrame":69},"Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item","ALL","18 Years",{"inclusion":75,"exclusion":81,"raw_text":88},[76,77,78,79,80],"Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent","Documented estrogen receptor (ER)-positive and\u002For progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines, defined as \\>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)","Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen","Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)","Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)",[82,83,84,85,86,87],"Metaplastic breast cancer","Radiotherapy within 2 weeks before randomization","Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)","Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes","Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible","Any history of leptomeningeal disease or carcinomatous meningitis","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n* Documented estrogen receptor (ER)-positive and\u002For progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines, defined as \\>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)\n* Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen\n* Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n\nExclusion Criteria:\n\n* Metaplastic breast cancer\n* Radiotherapy within 2 weeks before randomization\n* Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible\n* Any history of leptomeningeal disease or carcinomatous meningitis",[90,91],"ADULT","OLDER_ADULT",[93,102,109,117,125,132,139,146,153,161,165,169,176,185,193,201,208,217,224,232,239,247,254,261,268,275,283,290,297,306,314,322,330,337,341,350,358,365,370,377,384,388,393,397,404,411,420,426,433,440,444,451,459,466],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"Los Angeles Cancer Network - Anaheim","Anaheim","California","92805","United States",{"lat":100,"lon":101},33.83529,-117.9145,{"facility":103,"status":8,"city":104,"state":96,"zip":105,"country":98,"geoPoint":106},"Stanford Cancer Institute","Palo Alto","94304",{"lat":107,"lon":108},37.44188,-122.14302,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":98,"geoPoint":114},"Avera Cancer Institute - Marshall","Marshall","Minnesota","56258",{"lat":115,"lon":116},44.4469,-95.78835,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":98,"geoPoint":122},"Avera Cancer Institute - Aberdeen","Aberdeen","South Dakota","57401",{"lat":123,"lon":124},45.4647,-98.48648,{"facility":126,"status":8,"city":127,"state":120,"zip":128,"country":98,"geoPoint":129},"Avera Cancer Institute - Mitchell","Mitchell","57301",{"lat":130,"lon":131},43.70943,-98.0298,{"facility":133,"status":8,"city":134,"state":120,"zip":135,"country":98,"geoPoint":136},"Avera Cancer Institute - Pierre, SD","Pierre","57501",{"lat":137,"lon":138},44.36832,-100.35097,{"facility":140,"status":8,"city":141,"state":120,"zip":142,"country":98,"geoPoint":143},"Avera Cancer Institute","Sioux Falls","57105",{"lat":144,"lon":145},43.54369,-96.72796,{"facility":147,"status":8,"city":148,"state":120,"zip":149,"country":98,"geoPoint":150},"AMG Oncology and Hematology Avera Cancer Institute - Yankton","Yankton","57078",{"lat":151,"lon":152},42.87111,-97.39728,{"facility":154,"status":8,"city":155,"zip":156,"country":157,"geoPoint":158},"Inst. Alexander Fleming","Buenos Aires","C1426ANZ","Argentina",{"lat":159,"lon":160},-34.61315,-58.37723,{"facility":162,"status":8,"city":163,"zip":164,"country":157},"Centro Oncologico Korben","Caba","C1426AGE",{"facility":166,"status":8,"city":167,"zip":168,"country":157},"Centro Médico Fleischer","Capital Federal","C1414",{"facility":170,"status":8,"city":171,"zip":172,"country":157,"geoPoint":173},"Sanatorio de la Mujer","Rosario","S2000ORE",{"lat":174,"lon":175},-32.94682,-60.63932,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":181,"geoPoint":182},"Hospital Santa Rita de Cassia Vitoria","Vitória","Espírito Santo","29043-260","Brazil",{"lat":183,"lon":184},-20.31944,-40.33778,{"facility":186,"status":8,"city":187,"state":188,"zip":189,"country":181,"geoPoint":190},"Hospital Brasilia","Brasília","Federal District","71.635-610",{"lat":191,"lon":192},-15.77972,-47.92972,{"facility":194,"status":8,"city":195,"state":196,"zip":197,"country":181,"geoPoint":198},"Ictrials Pesquisa e Desenvolvimento","Curitiba","Paraná","80510-130",{"lat":199,"lon":200},-25.42778,-49.27306,{"facility":202,"status":8,"city":203,"state":203,"zip":204,"country":181,"geoPoint":205},"Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda","São Paulo","01317-000",{"lat":206,"lon":207},-23.5475,-46.63611,{"facility":209,"status":8,"city":210,"state":211,"zip":212,"country":213,"geoPoint":214},"Ottawa General Hospital","Ottawa","Ontario","K1H 8L6","Canada",{"lat":215,"lon":216},45.41117,-75.69812,{"facility":218,"status":8,"city":219,"state":211,"zip":220,"country":213,"geoPoint":221},"Sunnybrook Health Science Centre","Toronto","M4N 3M5",{"lat":222,"lon":223},43.70643,-79.39864,{"facility":225,"status":8,"city":226,"state":227,"zip":228,"country":213,"geoPoint":229},"CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital","Chicoutimi","Quebec","G7H 5H6",{"lat":230,"lon":231},48.41963,-71.06369,{"facility":233,"status":8,"city":234,"state":227,"zip":235,"country":213,"geoPoint":236},"McGill University","Montreal","H4A 3J1",{"lat":237,"lon":238},45.50884,-73.58781,{"facility":240,"status":8,"city":241,"zip":242,"country":243,"geoPoint":244},"Centre Oscar Lambret","Lille","59020","France",{"lat":245,"lon":246},50.63391,3.05512,{"facility":248,"status":8,"city":249,"zip":250,"country":243,"geoPoint":251},"Centre Leon Berard","Lyon","69008",{"lat":252,"lon":253},45.74906,4.84789,{"facility":255,"status":8,"city":256,"zip":257,"country":243,"geoPoint":258},"Institut Paoli Calmettes","Marseille","13273",{"lat":259,"lon":260},43.29695,5.38107,{"facility":262,"status":8,"city":263,"zip":264,"country":243,"geoPoint":265},"Institut Régional du Cancer de Montpellier","Montpellier","34298",{"lat":266,"lon":267},43.61093,3.87635,{"facility":269,"status":8,"city":270,"zip":271,"country":243,"geoPoint":272},"Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)","Toulouse","31059",{"lat":273,"lon":274},43.60426,1.44367,{"facility":276,"status":8,"city":277,"zip":278,"country":279,"geoPoint":280},"Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin","Aachen","52074","Germany",{"lat":281,"lon":282},50.77664,6.08342,{"facility":284,"status":8,"city":285,"zip":286,"country":279,"geoPoint":287},"Nationales Centrum für Tumorerkrankungen (NCT)","Heidelberg","69120",{"lat":288,"lon":289},49.40768,8.69079,{"facility":291,"status":8,"city":292,"zip":293,"country":279,"geoPoint":294},"Universitätsklinik Tübingen","Tübingen","72076",{"lat":295,"lon":296},48.52266,9.05222,{"facility":298,"status":8,"city":299,"state":300,"zip":301,"country":302,"geoPoint":303},"Istituto Nazionale Tumori Irccs Fondazione g. PASCALE","Naples","Campania","80131","Italy",{"lat":304,"lon":305},40.85216,14.26811,{"facility":307,"status":8,"city":308,"state":309,"zip":310,"country":302,"geoPoint":311},"IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola","Meldola","Emilia-Romagna","47014",{"lat":312,"lon":313},44.12775,12.0626,{"facility":315,"status":8,"city":316,"state":317,"zip":318,"country":302,"geoPoint":319},"Università Campus Bio-Medico di Roma","Rome","Lazio","128",{"lat":320,"lon":321},41.89193,12.51133,{"facility":323,"status":8,"city":324,"state":325,"zip":326,"country":302,"geoPoint":327},"Asst Papa Giovanni XXIII","Bergamo","Lombardy","24127",{"lat":328,"lon":329},45.69601,9.66721,{"facility":331,"status":8,"city":332,"state":325,"zip":333,"country":302,"geoPoint":334},"Ospedale San Raffaele","Milan","20132",{"lat":335,"lon":336},45.46427,9.18951,{"facility":338,"status":8,"city":332,"state":325,"zip":339,"country":302,"geoPoint":340},"Irccs Istituto Nazionale Dei Tumori (Int)","20133",{"lat":335,"lon":336},{"facility":342,"status":8,"city":343,"state":344,"zip":345,"country":346,"geoPoint":347},"Instituto Nacional De Cancerologia","Distrito Federal","Mexico CITY (federal District)","14000","Mexico",{"lat":348,"lon":349},16.59,-93.02694,{"facility":351,"status":8,"city":352,"state":353,"zip":354,"country":346,"geoPoint":355},"Centro de Investigacion Clinica de Oaxaca","Oaxaca City","Oaxaca","68020",{"lat":356,"lon":357},17.06025,-96.72544,{"facility":359,"status":8,"city":360,"zip":361,"country":346,"geoPoint":362},"Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde","Guadalajara","44280",{"lat":363,"lon":364},20.67738,-103.34749,{"facility":366,"status":8,"city":367,"zip":368,"country":369},"Instytut \"Centrum Zdrowia Matki Polki\"","?ód?","93-338","Poland",{"facility":371,"status":8,"city":372,"zip":373,"country":369,"geoPoint":374},"Bialostockie Centrum Onkologii","Bialystok","15-027",{"lat":375,"lon":376},53.13333,23.16433,{"facility":378,"status":8,"city":379,"zip":380,"country":369,"geoPoint":381},"COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej","Lublin","20-090",{"lat":382,"lon":383},51.25058,22.57009,{"facility":385,"status":8,"city":386,"zip":387,"country":369},"Dolno?l?skie Centrum Onkologii","Wroc?aw","53-413",{"facility":389,"status":8,"city":390,"zip":391,"country":392},"Soon Chun Hyang University Cheonan Hospital","Dongnam-gu, Cheonan-si","31151","South Korea",{"facility":394,"status":8,"city":395,"zip":396,"country":392},"Gachon University Gil Medical Center","Namdong-Gu","21565",{"facility":398,"status":8,"city":399,"zip":400,"country":392,"geoPoint":401},"Seoul National University Bundang Hospital","Seongnam-si","13605",{"lat":402,"lon":403},37.43861,127.13778,{"facility":405,"status":8,"city":406,"zip":407,"country":392,"geoPoint":408},"Seoul National University Hospital","Seoul","03080",{"lat":409,"lon":410},37.566,126.9784,{"facility":412,"status":8,"city":413,"state":414,"zip":415,"country":416,"geoPoint":417},"ICO L'Hospitalet","L'Hospitalet de Llobregat","Barcelona","08908","Spain",{"lat":418,"lon":419},41.35967,2.10028,{"facility":421,"status":8,"city":414,"zip":422,"country":416,"geoPoint":423},"Hospital Clinic Barcelona","08036",{"lat":424,"lon":425},41.38879,2.15899,{"facility":427,"status":8,"city":428,"zip":429,"country":416,"geoPoint":430},"Hospital Universitario Clínico San Cecilio","Granada","18016",{"lat":431,"lon":432},37.18817,-3.60667,{"facility":434,"status":8,"city":435,"zip":436,"country":416,"geoPoint":437},"Hospital Ramon y Cajal","Madrid","28034",{"lat":438,"lon":439},40.4165,-3.70256,{"facility":441,"status":8,"city":435,"zip":442,"country":416,"geoPoint":443},"Hospital Universitario 12 de Octubre","28041",{"lat":438,"lon":439},{"facility":445,"status":8,"city":446,"zip":447,"country":416,"geoPoint":448},"Hospital Clinico Universitario de Valencia","Valencia","46010",{"lat":449,"lon":450},39.47391,-0.37966,{"facility":452,"status":8,"city":453,"zip":454,"country":455,"geoPoint":456},"Leicester Royal Infirmary","Leicester","LE1 5WWi","United Kingdom",{"lat":457,"lon":458},52.6386,-1.13169,{"facility":460,"status":8,"city":461,"zip":462,"country":455,"geoPoint":463},"Royal Free Hospital","London","NW3 2QG",{"lat":464,"lon":465},51.50853,-0.12574,{"facility":467,"status":8,"city":468,"zip":469,"country":455,"geoPoint":470},"Christie Hospital Nhs Trust","Manchester","M20 4GJ",{"lat":471,"lon":472},53.48095,-2.23743,[474,479],{"name":475,"role":476,"phone":477,"email":478},"Reference Study ID Number: CO46274 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":480,"role":476},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[482],{"name":483,"affiliation":13,"role":484},"Clinical Trials","STUDY_DIRECTOR",[],[487],{"label":488,"url":489},"Please use this form to submit your questions for a faster response: https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.","https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"nct_id":4,"conditions":491,"biomarkers":493},[492],"Breast Carcinoma",[494],"Chromosome 8p",{"nct_id":4,"found":496,"summary":497,"prompt_version":507},true,{"design":498,"status":499,"heading":500,"summary":501,"follow_up":502,"word_count":503,"commitments":504,"compensation":505,"drugs_mentioned":506},"This is an interventional study comparing two treatment combinations. It plans to enroll 80 participants.","completed","Advanced Breast Cancer Study: Inavolisib, Ribociclib, and Fulvestrant","This study is looking at a new combination of medicines for people with advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), and has become resistant to hormone therapy. We are testing if adding inavolisib to ribociclib and fulvestrant works better than a placebo (an inactive substance) combined with ribociclib and fulvestrant. We want to see how many participants have their cancer shrink or disappear (objective response) over about two years. You may be able to join if you are an adult with this type of breast cancer that has spread or cannot be removed by surgery or radiation, and your tumor is ER-positive and\u002For PR-positive. We plan to enroll 80 participants.","The primary endpoint, measuring objective response, is assessed for up to approximately 2 years.",114,"Not specified in the trial record.","Not stated in the trial record.",[31,36,41,45],"v2"]