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
Start Date
4/9/2025
Completion Date
5/30/2032
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Inavolisib
Placebo
CDK4/6i
Letrozole
Conditions
Locations
The Dignity Health Cancer Institute
Phoenix, Arizona 85004
United States
Disney Family Cancer Center
Burbank, California 91505
United States
Scripps Health
La Jolla, California 92040
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United States
Ellison Institute of Technology
Los Angeles, California 90064
United States
Palo Alto Medical Foundation Research Center
Palo Alto, California 94301
United States
Kaiser Permanente - San Marcos
San Marcos, California 92069
United States
Palo Alto Medical Foundation Research Center
San Mateo, California 94401
United States
Palo Alto Medical Foundation Research Center
Sunnyvale, California 94086
United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida 32207
United States
Tallahassee Memorial HealthCare
Tallahassee, Florida 32308
United States
Moffitt Cancer Center-McKinley Campus
Tampa, Florida 33612
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia 30060
United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois 62269
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Baptist Health Lexington
Lexington, Kentucky 40503
United States
Baptist Health Hamburg
Lexington, Kentucky 40509
United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536
United States
University of Louisville Hospital
Louisville, Kentucky 40202
United States
Baptist Health Louisville
Louisville, Kentucky 40207
United States
Velocity Clinical Research
Annapolis, Maryland 21401
United States
University of Maryland
Baltimore, Maryland 21201
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503
United States
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
HCA Midwest Health
Kansas City, Missouri 64132
United States
Nebraska Cancer Specialists
Grand Island, Nebraska 68803
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130-2042
United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey 08816
United States
Summit Medical Group
Florham Park, New Jersey 07932
United States
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
New York, New York 10011
United States
Mount Sinai West
New York, New York 10019
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44915
United States
Hillcrest Hospital
Mayfield Heights, Ohio 44124
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy
Portland, Oregon 97225
United States
UPMC Hillman Cancer Center - Magee-Women?s Hospital
Pittsburgh, Pennsylvania 15213
United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina 29607
United States
West Cancer Center
Germantown, Tennessee 38138
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37204
United States
JPS Health Network
Fort Worth, Texas 76104
United States
Community Clinical Trials
Kingwood, Texas 77339
United States
Huntsman Cancer Hospital at the University of Utah
Salt Lake City, Utah 84113
United States
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington 98026
United States
Providence Regional Cancer Partnership
Everett, Washington 98201-1621
United States
Swedish Cancer Institute - Issaquah
Seattle, Washington 98104
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
Northwest Medical Specialties
Tacoma, Washington 98405
United States
Centro Oncologico Korben
Caba, C1426AGE
Argentina
Centro Médico Fleischer
Capital Federal, C1414
Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, 5016
Argentina
Instituto de Oncologia de Rosario
Rosario, S2013KZE
Argentina
Centro Oncológico de Excelencia
San Juan, J5400
Argentina
Blacktown Hospital
Blacktown, New South Wales 2148
Australia
Royal North Shore Hospital
St Leonards, New South Wales 2065
Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
Australia
Maroondah hospital;Oncology clinical trials
Ringwood, Victoria 3135
Australia
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará 60336-232
Brazil
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo 29043-260
Brazil
Obras Sociais Irma Dulce - Osid
Salvador, Estado de Bahia 40415-006
Brazil
Hospital Araujo Jorge
Goiânia, Goiás 74605-070
Brazil
Centro de Oncologia de Alfenas
Alfenas, Minas Gerais 37130-087
Brazil
Hospital do Câncer de Londrina
Londrina, Paraná 86015-520
Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco 50040-000
Brazil
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Piauí 64049-200
Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo 14784-400
Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo 01246-000
Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo 01317-001
Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120
Brazil
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta T2N 4C2
Canada
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
Canada
The Moncton Hospital
Moncton, New Brunswick E1C 6Z8
Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario K1H 8L6
Canada
Sault Area Hospital
Sault Ste. Marie, Ontario P6B 0A8
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
St. Joseph's Health Centre
Toronto, Ontario M6R 1B5
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C1
Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec H4J 1C5
Canada
Unité de Recherche Clinique du CISSS de Laurentides
Saint-Jérôme, Quebec J7Z 2V4
Canada
Xiangyang Central Hospital
Xiangyang, Hubei 441106
China
Peking Union Medical College Hospital
Beijing, 100032
China
Hunan Cancer Hospital
Changsha, 410013
China
West China Hospital of Sichuan University
Chengdu, 610041
China
Sichuan Provincial People's Hospital
Chengdu, 610072
China
Sun yat-sen University Cancer Center
Guangzhou, 510060
China
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou,
China
Zhejiang Cancer Hospital
Hangzhou, 310022
China
Harbin Medical University Cancer Hospital
Harbin, 150081
China
Jiangmen Central Hospital
Jiangmen, 529030
China
Shandong Cancer Hospital
Jinan, 250117
China
Jinhua municipal central hospital
Jinhua, 321083
China
Yunnan Cancer Hospital
Kunming, 650118
China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
China
Shantou Center Hospital
Shantou, 515031
China
Tianjin Cancer Hospital
Tianjin, 300000
China
Tianjin Cancer hospital Airport hospital
Tianjin, 300300
China
Xinjiang Medical University Cancer Hospital
Ürümqi, 830011
China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, 710004
China
Shanxi Provincial People's Hospital
Xi'an, 710068
China
ICO Paul Papin
Angers, 49055
France
Centre Oscar Lambret
Lille, 59020
France
Centre Cancerologie Grand Montpellier
Montpellier, 34070
France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
Paris, 75005
France
Centre CARIO - HPCA
Plérin, 22190
France
Chu La Miletrie
Poitiers, 86021
France
Centre Eugene Marquis
Rennes, 35042
France
Centre Henri Becquerel
Rouen, 76038
France
HOPITAL RENE HUGUENIN- Institut Curie
Saint-Cloud, 92211
France
Ico Rene Gauducheau
Saint-Herblain, 44805
France
Institut Universitaire de Cancer de Toulouse Oncopole
Toulouse, 31100
France
Gustave Roussy
Villejuif, 94805
France
St. Elisabeth Krankenhaus Köln GmbH
Cologne, 50935
Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
Germany
Universitätsklinikum Essen
Essen, 45122
Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, 45136
Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, 20357
Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625
Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, 56068
Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225
Germany
Universitätsklinikum Münster
Münster, 48149
Germany
Klinikum Ernst von Bergmann
Potsdam, 14467
Germany
Caritas-Krankenhaus St. Josef
Regensburg, 93053
Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113
Germany
Universitätsklinik Tübingen
Tübingen, 72076
Germany
Universitätsklinikum Ulm Am Michelsberg
Ulm, 89075
Germany
Az. Osp. G. Panico
Tricase (LE), Apulia 73039
Italy
A.O. S. Anna e San Sebastiano
Caserta, Campania 81100
Italy
A.O. Universitaria Federico II Di Napoli
Naples, Campania 80131
Italy
U.O.C. Oncologia Medica Senologica
Naples, Campania 80131
Italy
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna 40138
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna 47014
Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna 41100
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio 00168
Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy 24127
Italy
Ospedale San Raffaele
Milan, Lombardy 20132
Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy 20133
Italy
Istituto Clinico Humanitas
Rozzano, Lombardy 20089
Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily 95045
Italy
Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic
Bolzano, Trentino-Alto Adige 39100
Italy
Ospedale Civile - Livorno
Livorno, Tuscany 57124
Italy
University of Eastern Piedmont - Maggiore della Carità University Hospital
Novara, Umbria 28100
Italy
A.O. Santa Maria Terni
Terni, Umbria 05100
Italy
Chiba Cancer Center
Chiba, 260-8717
Japan
Fukushima Medical University Hospital
Fukushima, 960-1295
Japan
Hiroshima University Hospital
Hiroshima, 734-8551
Japan
Hokkaido University Hospital
Hokkaido, 060-8648
Japan
Kanagawa Cancer Center
Kanagawa, 241-8515
Japan
Tokai University Hospital
Kanagawa, 259-1193
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Saitama Medical University International Medical Center
Saitama, 350-1298
Japan
The Cancer Inst. Hosp. of JFCR
Tokyo, 135-8550
Japan
Instituto Nacional De Cancerologia
Distrito Federal, Mexico CITY (federal District) 14000
Mexico
Hospital General de Mexico
MexicoCiudad de México, Nuevo León 6726
Mexico
Hospital Zambrano Hellion TecSalud
Monterrey, Nuevo León
Mexico
Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V.
Ciudad de Huajuapan de León, Oaxaca 69007
Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca 68020
Mexico
Centro Estatal de Cancerologia de Chihuahua
Chihuahua City, 31000
Mexico
Iem-Fucam
D.F., 04980
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
Mexico
Instytut "Centrum Zdrowia Matki Polki"
?ód?, 93-338
Poland
Bialostockie Centrum Onkologii
Bialystok, 15-027
Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500
Poland
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581
Poland
Szpital Miejski Specjalistyczny Narutowicza
Krakow, 31-202
Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090
Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, 61-866
Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, 35-021
Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, 02-781
Poland
Dolno?l?skie Centrum Onkologii
Wroc?aw, 53-413
Poland
PanOncology Trials
San Juan, 00935
Puerto Rico
Linksfield Oncology Inc.
Johannesburg, 2192
South Africa
Abraham Oncology
Richards Bay, 3900
South Africa
Wits Clinical Research
Soweto, 2013
South Africa
Kyungpook National University Chilgok Hospital
Daegu, 41404
South Korea
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, 31151
South Korea
National Cancer Center
Goyang-si, 10408
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Gangnam Severance Hospital
Seoul, 06273
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital General Universitario de Elche
Elche, Alicante 03203
Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital de Navarra
Pamplona/iruña, Navarre 31008
Spain
Hospital de Basurto
Bilbao, Vizcaya 48013
Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Spain
Hospital Universitario de la Princesa
Madrid, 28006
Spain
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
Madrid, 28007
Spain
Hospital General Univ. Gregorio Maranon
Madrid, 28009
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040
Spain
Hospital Universitario 12 De Octubre
Madrid, 28041
Spain
Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia
Málaga, 29011
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, 46009
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Kantonsspital Baden Zentrum für Onkologie und Hämatologie
Baden, 5404
Switzerland
Universitätsspital Basel
Basel, 4031
Switzerland
CHUV
Lausanne, 1011
Switzerland
Luzerner Kantonsspital
Lucerne, 6004
Switzerland
Chia-Yi Christian Hospital
Chiayi City, 600566
Taiwan
Taichung Veterans General Hospital
Taichung, 407219
Taiwan
National Cheng Kung Uni Hospital
Tainan, 704
Taiwan
National Taiwan Uni Hospital
Taipei, 100
Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112019
Taiwan
Taipei Veterans General Hospital
Taipei, 112201
Taiwan
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
Ankara, 06200
Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800
Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
Turkey (Türkiye)
Ba?c?lar Medipol Mega Üniversite Hastanesi
Istanbul, 34214
Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, 35360
Turkey (Türkiye)
Mersin City Education and Research Hospital
Mersin, 33240
Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, FY3 8NR
United Kingdom
Colchester General Hospital
Colchester, Essex, CO4 5JL
United Kingdom
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Princess Alexandra Hospital
Harlow, CM20 1QX
United Kingdom
St Bartholomew's Hospital
London, EC1M 6BQ
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
Mount Vernon & Watford Hospital Trust
Northwood, HA6 2RN
United Kingdom
Churchill Hospital - Oxford Cancer & Haematology Centre
Oxford, OX3 7LE
United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ
United Kingdom