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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
NCT06790693 · Hoffmann-La Roche
In plain English
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Official title
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
About this study
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
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 design
Enrollment target: 450 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-04-09
Estimated completion: 2032-05-30
Last updated: 2026-04-03
Interventions
Drug: InavolisibDrug: PlaceboDrug: CDK4/6iDrug: Letrozole
Primary outcomes
- • Progression-Free Survival (PFS) (From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years))
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WO45654 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (219)
Disney Family Cancer CenterRecruiting
Burbank, California, United States
Scripps HealthRecruiting
La Jolla, California, United States
Cancer and Blood Specialty ClinicRecruiting
Los Alamitos, California, United States
Ellison Institute of TechnologyRecruiting
Los Angeles, California, United States
Palo Alto Medical Foundation Research CenterRecruiting
Palo Alto, California, United States
Kaiser Permanente - San MarcosRecruiting
San Marcos, California, United States
Palo Alto Medical Foundation Research CenterRecruiting
San Mateo, California, United States
Palo Alto Medical Foundation Research CenterRecruiting
Sunnyvale, California, United States
Cancer Specialists of North Florida - JacksonvilleRecruiting
Jacksonville, Florida, United States
Tallahassee Memorial HealthCareRecruiting
Tallahassee, Florida, United States
Moffitt Cancer Center-McKinley CampusRecruiting
Tampa, Florida, United States
Northwest Georgia Oncology Centers PC - MariettaRecruiting
Marietta, Georgia, United States
Cancer Care Specialists of Central IllinoisRecruiting
O'Fallon, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Carle Cancer CenterRecruiting
Urbana, Illinois, United States
Baptist Health LexingtonRecruiting
Lexington, Kentucky, United States
Baptist Health HamburgRecruiting
Lexington, Kentucky, United States
University of Kentucky - Markey Cancer CenterRecruiting
Lexington, Kentucky, United States
University of Louisville HospitalRecruiting
Louisville, Kentucky, United States
Baptist Health LouisvilleRecruiting
Louisville, Kentucky, United States
Velocity Clinical ResearchRecruiting
Annapolis, Maryland, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Cancer & Hematology Centers of Western MichiganRecruiting
Grand Rapids, Michigan, United States
University of Minnesota Medical CenterRecruiting
Minneapolis, Minnesota, United States
HCA Midwest HealthRecruiting
Kansas City, Missouri, United States
Nebraska Cancer SpecialistsRecruiting
Grand Island, Nebraska, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Astera Cancer Care East BrunswickRecruiting
East Brunswick, New Jersey, United States
Summit Medical GroupRecruiting
Florham Park, New Jersey, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Fairview HospitalRecruiting
Cleveland, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Hillcrest HospitalRecruiting
Mayfield Heights, Ohio, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services PharmacyRecruiting
Portland, Oregon, United States
Bon Secours - St. Francis HospitalRecruiting
Greenville, South Carolina, United States
West Cancer CenterRecruiting
Germantown, Tennessee, United States
Community Clinical TrialsRecruiting
Kingwood, Texas, United States
Swedish Cancer Institute - Edmonds CampusRecruiting
Edmonds, Washington, United States
Providence Regional Cancer PartnershipRecruiting
Everett, Washington, United States
Swedish Cancer Institute - IssaquahRecruiting
Seattle, Washington, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Northwest Medical SpecialtiesRecruiting
Tacoma, Washington, United States
Centro Oncologico KorbenRecruiting
Caba, Argentina
Centro Médico FleischerRecruiting
Capital Federal, Argentina
Hospital Privado Centro Medico de CordobaRecruiting
Córdoba, Argentina
Instituto de Oncologia de RosarioRecruiting
Rosario, Argentina
Centro Oncológico de ExcelenciaRecruiting
San Juan, Argentina
Royal North Shore HospitalRecruiting
St Leonards, New South Wales, Australia
Lyell McEwin HospitalRecruiting
Elizabeth Vale, South Australia, Australia
Crio - Centro Regional Integrado de OncologiaRecruiting
Fortaleza, Ceará, Brazil
Hospital Santa Rita de Cassia VitoriaRecruiting
Vitória, Espírito Santo, Brazil
Obras Sociais Irma Dulce - OsidRecruiting
Salvador, Estado de Bahia, Brazil
Hospital Araujo JorgeRecruiting
Goiânia, Goiás, Brazil
Centro de Oncologia de AlfenasRecruiting
Alfenas, Minas Gerais, Brazil
Hospital do Câncer de LondrinaRecruiting
Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCPRecruiting
Recife, Pernambuco, Brazil
Vencer Oncoclínica - Centro de Pesquisa do PiauíRecruiting
Teresina, Piauí, Brazil
Santa Casa de Misericordia de Porto AlegreRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de BarretosRecruiting
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria LtdaRecruiting
São Paulo, São Paulo, Brazil
Instituto Nacional de Cancer - INCaRecruiting
Rio de Janeiro, Brazil
Arthur J.E. Child Comprehensive Cancer CenterRecruiting
Calgary, Alberta, Canada
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
CancerCare ManitobaRecruiting
Winnipeg, Manitoba, Canada
The Moncton HospitalRecruiting
Moncton, New Brunswick, Canada
The Ottawa Hospital Cancer CenterRecruiting
Ottawa, Ontario, Canada
Sault Area HospitalRecruiting
Sault Ste. Marie, Ontario, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
St. Joseph's Health CentreRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)Recruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de MontrealRecruiting
Montreal, Quebec, Canada
Unité de Recherche Clinique du CISSS de LaurentidesRecruiting
Saint-Jérôme, Quebec, Canada
Xiangyang Central HospitalRecruiting
Xiangyang, Hubei, China
Peking Union Medical College HospitalRecruiting
Beijing, China
Hunan Cancer HospitalRecruiting
Changsha, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, China
Sichuan Provincial People's HospitalRecruiting
Chengdu, China
Sun yat-sen University Cancer CenterRecruiting
Guangzhou, China
Sun Yat-Sen University Cancer Center - Huangpu CampusRecruiting
Guangzhou, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, China
Jiangmen Central HospitalRecruiting
Jiangmen, China
Shandong Cancer HospitalRecruiting
Jinan, China
Jinhua municipal central hospitalRecruiting
Jinhua, China
Yunnan Cancer HospitalRecruiting
Kunming, China
Guangxi Cancer Hospital of Guangxi Medical UniversityRecruiting
Nanning, China
Shantou Center HospitalRecruiting
Shantou, China
Tianjin Cancer HospitalRecruiting
Tianjin, China
Tianjin Cancer hospital Airport hospitalRecruiting
Tianjin, China
Xinjiang Medical University Cancer HospitalRecruiting
Ürümqi, China
The Second Affiliated Hospital of Xi'an Jiao Tong UniversityRecruiting
Xi'an, China
Shanxi Provincial People's HospitalRecruiting
Xi'an, China
ICO Paul PapinRecruiting
Angers, France
Centre Oscar LambretRecruiting
Lille, France
Centre Cancerologie Grand MontpellierRecruiting
Montpellier, France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.Recruiting
Paris, France
Centre CARIO - HPCARecruiting
Plérin, France
Chu La MiletrieRecruiting
Poitiers, France
Centre Eugene MarquisRecruiting
Rennes, France
Centre Henri BecquerelRecruiting
Rouen, France
HOPITAL RENE HUGUENIN- Institut CurieRecruiting
Saint-Cloud, France
Ico Rene GauducheauRecruiting
Saint-Herblain, France
Institut Universitaire de Cancer de Toulouse OncopoleRecruiting
Toulouse, France
Gustave RoussyRecruiting
Villejuif, France
St. Elisabeth Krankenhaus Köln GmbHRecruiting
Cologne, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität DresdenRecruiting
Dresden, Germany
Universitätsklinikum EssenRecruiting
Essen, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbHRecruiting
Essen, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus JerusalemRecruiting
Hamburg, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische OnkologieRecruiting
Hanover, Germany
Nationales Centrum für Tumorerkrankungen (NCT)Recruiting
Heidelberg, Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbRRecruiting
Koblenz, Germany
Dres. Andreas Köhler und Roswitha FuchsRecruiting
Langen, Germany
Universitätsklinikum MünsterRecruiting
Münster, Germany
Klinikum Ernst von BergmannRecruiting
Potsdam, Germany
Caritas-Krankenhaus St. JosefRecruiting
Regensburg, Germany
Caritas Klinik St. Theresia -Frauenklinik BrustzentrumRecruiting
Saarbrücken, Germany
Universitätsklinik TübingenRecruiting
Tübingen, Germany
Universitätsklinikum Ulm Am MichelsbergRecruiting
Ulm, Germany
Az. Osp. G. PanicoRecruiting
Tricase (LE), Apulia, Italy
A.O. S. Anna e San SebastianoRecruiting
Caserta, Campania, Italy
A.O. Universitaria Federico II Di NapoliRecruiting
Naples, Campania, Italy
U.O.C. Oncologia Medica SenologicaRecruiting
Naples, Campania, Italy
Policlinico S.Orsola-MalpighiRecruiting
Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede MeldolaRecruiting
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di ModenaRecruiting
Modena, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Lazio, Italy
Asst Papa Giovanni XXIIIRecruiting
Bergamo, Lombardy, Italy
Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)Recruiting
Milan, Lombardy, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Lombardy, Italy
Humanitas Centro Catanese Di OncologiaRecruiting
Misterbianco (CT), Sicily, Italy
Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia MedicRecruiting
Bolzano, Trentino-Alto Adige, Italy
Ospedale Civile - LivornoRecruiting
Livorno, Tuscany, Italy
University of Eastern Piedmont - Maggiore della Carità University HospitalRecruiting
Novara, Umbria, Italy
A.O. Santa Maria TerniRecruiting
Terni, Umbria, Italy
Chiba Cancer CenterRecruiting
Chiba, Japan
Fukushima Medical University HospitalRecruiting
Fukushima, Japan
Hiroshima University HospitalRecruiting
Hiroshima, Japan
Hokkaido University HospitalRecruiting
Hokkaido, Japan
Kanagawa Cancer CenterRecruiting
Kanagawa, Japan
Tokai University HospitalRecruiting
Kanagawa, Japan
Saitama Medical University International Medical CenterRecruiting
Saitama, Japan
The Cancer Inst. Hosp. of JFCRRecruiting
Tokyo, Japan
Instituto Nacional De CancerologiaRecruiting
Distrito Federal, Mexico CITY (federal District), Mexico
Hospital General de MexicoRecruiting
MexicoCiudad de México, Nuevo León, Mexico
Hospital Zambrano Hellion TecSaludRecruiting
Monterrey, Nuevo León, Mexico
Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V.Recruiting
Ciudad de Huajuapan de León, Oaxaca, Mexico
Centro de Investigacion Clinica de OaxacaRecruiting
Oaxaca City, Oaxaca, Mexico
Centro Estatal de Cancerologia de ChihuahuaRecruiting
Chihuahua City, Mexico
Iem-FucamRecruiting
D.F., Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
Guadalajara, Mexico
Instytut "Centrum Zdrowia Matki Polki"Recruiting
?ód?, Poland
Bialostockie Centrum OnkologiiRecruiting
Bialystok, Poland
Przychodnia Lekarska KOMED, Roman KaraszewskiRecruiting
Konin, Poland
Szpital Wojewódzki im. Miko?aja KopernikaRecruiting
Koszalin, Poland
Szpital Miejski Specjalistyczny NarutowiczaWithdrawn
Krakow, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii DziennejRecruiting
Lublin, Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-CurieRecruiting
Późna, Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w RzeszowieRecruiting
Rzeszów, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.BadRecruiting
Warsaw, Poland
Dolno?l?skie Centrum OnkologiiRecruiting
Wroc?aw, Poland
PanOncology TrialsRecruiting
San Juan, Puerto Rico
Linksfield Oncology Inc.Recruiting
Johannesburg, South Africa
Abraham OncologyRecruiting
Richards Bay, South Africa
Wits Clinical ResearchRecruiting
Soweto, South Africa
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
Soon Chun Hyang University Cheonan HospitalRecruiting
Dongnam-gu, Cheonan-si, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Gangnam Severance HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital General Universitario de ElcheRecruiting
Elche, Alicante, Spain
ICO L'HospitaletRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de NavarraRecruiting
Pamplona/iruña, Navarre, Spain
Hospital de BasurtoRecruiting
Bilbao, Vizcaya, Spain
Vall d'Hebron Institute of Oncology (VHIO), BarcelonaRecruiting
Barcelona, Spain
Hospital Universitario de la PrincesaRecruiting
Madrid, Spain
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación OncológicaRecruiting
Madrid, Spain
Hospital General Univ. Gregorio MaranonRecruiting
Madrid, Spain
Hospital Universitario Infanta LeonorRecruiting
Madrid, Spain
Hospital Universitario Clínico San CarlosRecruiting
Madrid, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria;Servicio de OncologiaRecruiting
Málaga, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Spain
Fundacion Instituto Valenciano de Oncologia (IVO)Recruiting
Valencia, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Kantonsspital Baden Zentrum für Onkologie und HämatologieRecruiting
Baden, Switzerland
Universitätsspital BaselRecruiting
Basel, Switzerland
CHUVRecruiting
Lausanne, Switzerland
Luzerner KantonsspitalRecruiting
Lucerne, Switzerland
Chia-Yi Christian HospitalRecruiting
Chiayi City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung Uni HospitalRecruiting
Tainan, Taiwan
National Taiwan Uni HospitalRecruiting
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Abdurrahman Yurtarslan Onkoloji Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Ankara City HospitalRecruiting
Ankara, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi OnkolojiRecruiting
Bakirkoy / Istanbul, Turkey (Türkiye)
Ba?c?lar Medipol Mega Üniversite HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Izmir Ataturk Training and Research HospitalRecruiting
Izmir, Turkey (Türkiye)
Mersin City Education and Research HospitalRecruiting
Mersin, Turkey (Türkiye)
Blackpool Victoria HospitalRecruiting
Blackpool, United Kingdom
Colchester General HospitalRecruiting
Colchester, Essex, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
Princess Alexandra HospitalRecruiting
Harlow, United Kingdom
St Bartholomew's HospitalRecruiting
London, United Kingdom
Royal Free HospitalRecruiting
London, United Kingdom
Mount Vernon & Watford Hospital TrustRecruiting
Northwood, United Kingdom
Churchill Hospital - Oxford Cancer & Haematology CentreRecruiting
Oxford, United Kingdom
Weston Park HospitalRecruiting
Sheffield, United Kingdom