A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)

June 1, 2026 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Argentina
      • Caba, Argentina, C1426AGE
        • Recruiting
        • Centro Oncologico Korben
      • Capital Federal, Argentina, C1414
        • Recruiting
        • Centro Medico Fleischer
      • Córdoba, Argentina, 5016
        • Recruiting
        • Hospital Privado Centro Médico de Córdoba
      • Rosario, Argentina, S2013KZE
        • Recruiting
        • Instituto de Oncología de Rosario
      • San Juan, Argentina, J5400
        • Recruiting
        • Centro Oncológico de Excelencia
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Recruiting
        • Lyell McEwin Hospital
    • Victoria
      • Ringwood, Victoria, Australia, 3135
        • Recruiting
        • Maroondah hospital;Oncology clinical trials
  • Brazil
      • Rio de Janeiro, Brazil, 20560-120
        • Recruiting
        • Instituto Nacional de Cancer - INCa
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-232
        • Recruiting
        • Crio - Centro Regional Integrado de Oncologia
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • Recruiting
        • Hospital Santa Rita de Cassia Vitoria
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40415-006
        • Recruiting
        • Obras Sociais Irma Dulce - Osid
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Recruiting
        • Hospital Araujo Jorge
    • Minas Gerais
      • Alfenas, Minas Gerais, Brazil, 37130-087
        • Recruiting
        • Centro de Oncologia de Alfenas
    • Paraná
      • Londrina, Paraná, Brazil, 86015-520
        • Recruiting
        • Hospital do Cancer de Londrina
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital do Cancer de Pernambuco - HCP
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Recruiting
        • Vencer Oncoclínica - Centro de Pesquisa do Piauí
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Recruiting
        • Santa Casa de Misericordia de Porto Alegre
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Hospital de Câncer de Barretos
      • São Paulo, São Paulo, Brazil, 01246-000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • São Paulo, São Paulo, Brazil, 01317-001
        • Recruiting
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4C2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Center
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital Cancer Center
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Recruiting
        • Sault Area Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M6R 1B5
        • Recruiting
        • St. Joseph's Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4J 1C5
        • Recruiting
        • Hopital Du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Saint-Jérôme, Quebec, Canada, J7Z 2V4
        • Recruiting
        • Unité de Recherche Clinique du CISSS de Laurentides
  • China
      • Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
      • Changsha, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
      • Guangzhou, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center - Huangpu Campus
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Jiangmen, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
      • Jinan, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
      • Jinhua, China, 321083
        • Recruiting
        • Jinhua Municipal Central Hospital
      • Kunming, China, 650118
        • Recruiting
        • Yunnan Cancer Hospital
      • Nanning, China, 530021
        • Recruiting
        • Guangxi Cancer Hospital of Guangxi Medical University
      • Shantou, China, 515031
        • Recruiting
        • Shantou Center Hospital
      • Tianjin, China, 300000
        • Recruiting
        • Tianjin Cancer Hospital
      • Tianjin, China, 300300
        • Recruiting
        • Tianjin Cancer Hospital Airport Hospital
      • Xi'an, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiao Tong University
      • Xi'an, China, 710068
        • Recruiting
        • Shanxi Provincial People's Hospital
      • Ürümqi, China, 830011
        • Recruiting
        • Xinjiang Medical University Cancer Hospital
    • Hubei
      • Xiangyang, Hubei, China, 441106
        • Recruiting
        • Xiangyang Central Hospital
  • France
      • Angers, France, 49055
        • Recruiting
        • ICO Paul Papin
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
      • Montpellier, France, 34070
        • Recruiting
        • Centre Cancerologie Grand Montpellier
      • Paris, France, 75005
        • Recruiting
        • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
      • Plérin, France, 22190
        • Recruiting
        • Centre CARIO - HPCA
      • Poitiers, France, 86021
        • Recruiting
        • CHU La Miletrie
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugene Marquis
      • Rouen, France, 76038
        • Recruiting
        • Centre Henri Becquerel
      • Saint-Cloud, France, 92211
        • Recruiting
        • HOPITAL RENE HUGUENIN- Institut Curie
      • Saint-Herblain, France, 44805
        • Recruiting
        • Ico Rene Gauducheau
      • Toulouse, France, 31100
        • Recruiting
        • Institut Universitaire de Cancer de Toulouse Oncopole
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
  • Germany
      • Cologne, Germany, 50935
        • Recruiting
        • St. Elisabeth Krankenhaus Köln GmbH
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
      • Essen, Germany, 45122
        • Recruiting
        • Universitätsklinikum Essen
      • Essen, Germany, 45136
        • Recruiting
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
      • Hamburg, Germany, 20357
        • Recruiting
        • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
      • Heidelberg, Germany, 69120
        • Recruiting
        • Nationales Centrum für Tumorerkrankungen (NCT)
      • Koblenz, Germany, 56068
        • Recruiting
        • InVO - Institut für Versorgungsforschung in der Onkologie GbR
      • Langen, Germany, 63225
        • Recruiting
        • Dres. Andreas Köhler und Roswitha Fuchs
      • Münster, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
      • Potsdam, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann
      • Regensburg, Germany, 93053
        • Recruiting
        • Caritas-Krankenhaus St. Josef
      • Saarbrücken, Germany, 66113
        • Recruiting
        • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinik Tübingen
      • Ulm, Germany, 89075
        • Recruiting
        • Universitätsklinikum Ulm Am Michelsberg
  • Italy
    • Apulia
      • Tricase (LE), Apulia, Italy, 73039
        • Recruiting
        • Az. Osp. G. Panico
    • Campania
      • Caserta, Campania, Italy, 81100
        • Recruiting
        • A.O. S. Anna e San Sebastiano
      • Naples, Campania, Italy, 80131
        • Recruiting
        • A.O. Universitaria Federico II Di Napoli
      • Naples, Campania, Italy, 80131
        • Recruiting
        • U.O.C. Oncologia Medica Senologica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • Policlinico S.Orsola-Malpighi
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
      • Modena, Emilia-Romagna, Italy, 41100
        • Recruiting
        • A.O. Universitaria Policlinico Di Modena
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Rozzano, Lombardy, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
    • Sicily
      • Misterbianco (CT), Sicily, Italy, 95045
        • Recruiting
        • Humanitas Centro Catanese Di Oncologia
    • Trentino-Alto Adige
      • Bolzano, Trentino-Alto Adige, Italy, 39100
        • Recruiting
        • Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic
    • Tuscany
      • Livorno, Tuscany, Italy, 57124
        • Recruiting
        • Ospedale Civile - Livorno
    • Umbria
      • Novara, Umbria, Italy, 28100
        • Recruiting
        • University of Eastern Piedmont - Maggiore della Carità University Hospital
      • Terni, Umbria, Italy, 05100
        • Recruiting
        • A.O. Santa Maria Terni
  • Japan
      • Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
      • Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
      • Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center
      • Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center
      • Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Inst. Hosp. of JFCR
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Centro Estatal de Cancerología de Chihuahua
      • D.F., Mexico, 04980
        • Recruiting
        • Iem-Fucam
      • Guadalajara, Mexico, 44280
        • Recruiting
        • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
    • Mexico CITY (federal District)
      • Distrito Federal, Mexico CITY (federal District), Mexico, 14000
        • Recruiting
        • Instituto Nacional de Cancerologia
    • Nuevo León
      • MexicoCiudad de México, Nuevo León, Mexico, 6726
        • Recruiting
        • Hospital General de Mexico
      • Monterrey, Nuevo León, Mexico
        • Recruiting
        • Hospital Zambrano Hellion TecSalud
    • Oaxaca
      • Ciudad de Huajuapan de León, Oaxaca, Mexico, 69007
        • Recruiting
        • Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V.
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca
  • Poland
      • ?ód?, Poland, 93-338
        • Recruiting
        • Instytut "Centrum Zdrowia Matki Polki"
      • Bialystok, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii
      • Konin, Poland, 62-500
        • Recruiting
        • Przychodnia Lekarska KOMED, Roman Karaszewski
      • Koszalin, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Miko?aja Kopernika
      • Krakow, Poland, 31-202
        • Withdrawn
        • Szpital Miejski Specjalistyczny Narutowicza
      • Lublin, Poland, 20-090
        • Recruiting
        • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
      • Późna, Poland, 61-866
        • Recruiting
        • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
      • Rzeszów, Poland, 35-021
        • Recruiting
        • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
      • Warsaw, Poland, 02-781
        • Recruiting
        • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
      • Wroc?aw, Poland, 53-413
        • Recruiting
        • Dolno?l?skie Centrum Onkologii
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • PanOncology Trials
  • South Africa
      • Johannesburg, South Africa, 2192
        • Recruiting
        • Linksfield Oncology Inc.
      • Richards Bay, South Africa, 3900
        • Recruiting
        • Abraham Oncology
      • Soweto, South Africa, 2013
        • Recruiting
        • WITS Clinical Research
  • South Korea
      • Daegu, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
      • Dongnam-gu, Cheonan-si, South Korea, 31151
        • Recruiting
        • Soon Chun Hyang University Cheonan Hospital
      • Goyang-si, South Korea, 10408
        • Recruiting
        • National Cancer Center
      • Seongnam-si, South Korea, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Univ. Gregorio Maranon
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain, 28007
        • Recruiting
        • IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
      • Málaga, Spain, 29011
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46009
        • Recruiting
        • Fundacion Instituto Valenciano de Oncologia (IVO)
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • ICO L'Hospitalet
    • Navarre
      • Pamplona/iruña, Navarre, Spain, 31008
        • Recruiting
        • Hospital de Navarra
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Recruiting
        • Hospital de Basurto
  • Switzerland
      • Baden, Switzerland, 5404
        • Recruiting
        • Kantonsspital Baden Zentrum für Onkologie und Hämatologie
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitätsspital Basel
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV
      • Lucerne, Switzerland, 6004
        • Recruiting
        • Luzerner Kantonsspital
  • Taiwan
      • Chiayi City, Taiwan, 600566
        • Recruiting
        • Chia-Yi Christian Hospital
      • Taichung, Taiwan, 407219
        • Recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung Uni Hospital
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan Uni Hospital
      • Taipei, Taiwan, 112019
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara City Hospital
      • Bakirkoy / Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Ba?c?lar Medipol Mega Üniversite Hastanesi
      • Izmir, Turkey (Türkiye), 35360
        • Recruiting
        • Izmir Ataturk Training and Research Hospital
      • Mersin, Turkey (Türkiye), 33240
        • Recruiting
        • Mersin City Education and Research Hospital
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Victoria Hospital
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Recruiting
        • Colchester General Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital
      • Harlow, United Kingdom, CM20 1QX
        • Recruiting
        • Princess Alexandra Hospital
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
      • London, United Kingdom, EC1M 6BQ
        • Recruiting
        • St Bartholomew's Hospital
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon & Watford Hospital Trust
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital - Oxford Cancer & Haematology Centre
      • Sheffield, United Kingdom, S10 2SJ
        • Recruiting
        • Weston Park Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • The Dignity Health Cancer Institute
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Disney Family Cancer Center
      • La Jolla, California, United States, 92040
        • Recruiting
        • Scripps Health
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90064
        • Recruiting
        • Ellison Institute of Technology
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Palo Alto Medical Foundation Research Center
      • San Marcos, California, United States, 92069
        • Recruiting
        • Kaiser Permanente - San Marcos
      • San Mateo, California, United States, 94401
        • Recruiting
        • Palo Alto Medical Foundation Research Center
      • Sunnyvale, California, United States, 94086
        • Recruiting
        • Palo Alto Medical Foundation Research Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Cancer Specialists of North Florida - Jacksonville
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Memorial HealthCare
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center-McKinley Campus
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers PC - Marietta
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Specialists of Central Illinois
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky - Markey Cancer Center
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Baptist Health Hamburg
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Hospital
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Velocity Clinical Research
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer & Hematology Centers of Western Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • HCA Midwest Health
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • Nebraska Cancer Specialists
      • Omaha, Nebraska, United States, 68130-2042
        • Recruiting
        • Nebraska Cancer Specialists
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care East Brunswick
      • Florham Park, New Jersey, United States, 07932
        • Recruiting
        • Summit Medical Group
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
      • New York, New York, United States, 10011
        • Recruiting
        • The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Fairview Hospital
      • Cleveland, Ohio, United States, 44915
        • Recruiting
        • Cleveland Clinic Foundation
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Hillcrest Hospital
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Hillman Cancer Center - Magee-Women?s Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Bon Secours - St. Francis Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Community Clinical Trials
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute - Edmonds Campus
      • Everett, Washington, United States, 98201-1621
        • Recruiting
        • Providence Regional Cancer Partnership
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute - Issaquah
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women or men with histologically or cytologically confirmed carcinoma of the breast
  • Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Documented HER2-negative tumor according to ASCO/CAP guidelines
  • De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
  • Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
  • Confirmation of biomarker eligibility
  • Consent to provide fresh or archival tumor tissue specimen
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion Criteria:

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
  • Metaplastic breast cancer
  • Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Any history of leptomeningeal disease or carcinomatous meningitis
  • Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
  • Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
  • Symptomatic active lung disease
  • History of or active inflammatory bowel disease
  • Any active bowel inflammation
  • Prior hematopoietic stem cell or bone marrow transplantation
  • Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inavolisib + Letrozole + CDK4/6i
Participants will receive inavolisib, letrozole and CDK4/6i.
Drug: Inavolisib
Participants will receive oral inavolisib once daily (QD).
Other Names:
  • GDC-0077
  • Itovebi
Drug: Letrozole
Participants will receive oral letrozole QD.
Drug: CDK4/6i
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
Placebo Comparator: Placebo + Letrozole + CDK4/6i
Participants will receive placebo, letrozole and CDK4/6i.
Drug: Placebo
Participants will receive oral placebo QD.
Drug: Letrozole
Participants will receive oral letrozole QD.
Drug: CDK4/6i
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to 7 years)
From randomization to death from any cause (up to 7 years)
Investigator-assessed Objective Response Rate (ORR)
Time Frame: Up to 7 years
Up to 7 years
Investigator-assessed Duration of Response (DOR)
Time Frame: From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
Investigator-assessed Clinical Benefit Rate (CBR)
Time Frame: Up to 7 years
Up to 7 years
Time to Confirmed Deterioration (TTCD) in Pain
Time Frame: From baseline until end of follow-up (up to 7 years)
From baseline until end of follow-up (up to 7 years)
TTCD in Physical Function
Time Frame: From baseline until end of follow-up (up to 7 years)
From baseline until end of follow-up (up to 7 years)
TTCD in Role Function
Time Frame: From baseline until end of follow-up (up to 7 years)
From baseline until end of follow-up (up to 7 years)
TTCD in Global Health Status
Time Frame: From baseline until end of follow-up (up to 7 years)
From baseline until end of follow-up (up to 7 years)
Percentage of Participants with Adverse Events
Time Frame: From baseline until end of follow-up (up to 7 years)
From baseline until end of follow-up (up to 7 years)
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame: Up to 7 years
Up to 7 years
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)
Time Frame: Up to 7 years
Up to 7 years
Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE
Time Frame: Baseline up to 7 years
Baseline up to 7 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Time Frame: Baseline up to 7 years
Baseline up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

May 30, 2032

Study Completion (Estimated)

May 30, 2032

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO45654
  • 2024-516162-11-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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