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
NCT ID: NCT06790693
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-04-09
2032-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inavolisib + Letrozole + CDK4/6i
Participants will receive inavolisib, letrozole and CDK4/6i.
Inavolisib
Participants will receive oral inavolisib once daily (QD).
CDK4/6i
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Letrozole
Participants will receive oral letrozole QD.
Placebo + Letrozole + CDK4/6i
Participants will receive placebo, letrozole and CDK4/6i.
Placebo
Participants will receive oral placebo QD.
CDK4/6i
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Letrozole
Participants will receive oral letrozole QD.
Interventions
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Inavolisib
Participants will receive oral inavolisib once daily (QD).
Placebo
Participants will receive oral placebo QD.
CDK4/6i
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Letrozole
Participants will receive oral letrozole QD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Disney Family Cancer Center
Burbank, California, United States
Scripps Health
La Jolla, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Ellison Institute of Technology
Los Angeles, California, United States
Kaiser Permanente - San Marcos
San Marcos, California, United States
Moffitt Cancer Center-McKinley Campus
Tampa, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Baptist Health Hamburg
Lexington, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Velocity Clinical Research
Annapolis, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
HCA Midwest Health
Kansas City, Missouri, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy
Portland, Oregon, United States
West Cancer Center
Germantown, Tennessee, United States
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Centro Oncologico Korben
Caba, , Argentina
Centro Médico Fleischer
Capital Federal, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Instituto de Oncologia de Rosario
Rosario, , Argentina
Centro Oncológico de Excelencia
San Juan, , Argentina
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo, Brazil
Obras Sociais Irma Dulce - Osid
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Centro de Oncologia de Alfenas
Alfenas, Minas Gerais, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Piauí, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, , Brazil
CancerCare Manitoba
Winnipeg, Manitoba, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada
Unité de Recherche Clinique du CISSS de Laurentides
Saint-Jérôme, Quebec, Canada
Xiangyang Central Hospital
Xiangyang, Hubei, China
Peking Union Medical College Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Sichuan Provincial People's Hospital
Chengdu, , China
Sun yat-sen University Cancer Center
Guangzhou, , China
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangmen Central Hospital
Jiangmen, , China
Shandong Cancer Hospital
Jinan, , China
Jinhua municipal central hospital
Jinhua, , China
Yunnan Cancer Hospital
Kunming, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
Shantou Center Hospital
Shantou, , China
Tianjin Cancer Hospital
Tianjin, , China
Tianjin Cancer hospital Airport hospital
Tianjin, , China
Xinjiang Medical University Cancer Hospital
Ürümqi, , China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, , China
Shanxi Provincial People's Hospital
Xi'an, , China
Centre Cancerologie Grand Montpellier
Montpellier, , France
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
Paris, , France
Centre CARIO - HPCA
Plérin, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
HOPITAL RENE HUGUENIN- Institut Curie
Saint-Cloud, , France
Institut Universitaire de Cancer de Toulouse Oncopole
Toulouse, , France
Gustave Roussy
Villejuif, , France
St. Elisabeth Krankenhaus Köln GmbH
Cologne, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
Essen, , Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, , Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, , Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, , Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, , Germany
Universitätsklinikum Münster
Münster, , Germany
Caritas-Krankenhaus St. Josef
Regensburg, , Germany
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, , Germany
Universitätsklinik Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm Am Michelsberg
Ulm, , Germany
Az. Osp. G. Panico
Tricase (LE), Apulia, Italy
A.O. S. Anna e San Sebastiano
Caserta, Campania, Italy
A.O. Universitaria Federico II Di Napoli
Napoli, Campania, Italy
U.O.C. Oncologia Medica Senologica
Napoli, Campania, Italy
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, Italy
Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic
Bolzano, Trentino-Alto Adige, Italy
Ospedale Civile - Livorno
Livorno, Tuscany, Italy
University of Eastern Piedmont - Maggiore della Carità University Hospital
Novara, Umbria, Italy
A.O. Santa Maria Terni
Terni, Umbria, Italy
Instituto Nacional De Cancerologia
Distrito Federal, Mexico CITY (federal District), 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, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Centro Estatal de Cancerologia de Chihuahua
Chihuahua City, , Mexico
Iem-Fucam
D.F., , Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, , Mexico
Instytut "Centrum Zdrowia Matki Polki"
?ód?, , Poland
Bialostockie Centrum Onkologii
Bialystok, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, , Poland
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, , Poland
Szpital Miejski Specjalistyczny Narutowicza
Krakow, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, , Poland
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, , Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, , Poland
PanOncology Trials
San Juan, , Puerto Rico
Linksfield Oncology Inc.
Johannesburg, , South Africa
Abraham Oncology
Richards Bay, , South Africa
Wits Clinical Research
Soweto, , South Africa
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto Valenciano Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Chia-Yi Christian Hospital
Chiayi City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung Uni Hospital
Tainan, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, , Turkey (Türkiye)
Ba?c?lar Medipol Mega Üniversite Hastanesi
Istanbul, , Turkey (Türkiye)
Katip Celebi University Ataturk Training and Research Hospital
Izmir, , Turkey (Türkiye)
Mersin City Education and Research Hospital
Mersin, , Turkey (Türkiye)
Princess Alexandra Hospital
Harlow, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Churchill Hospital - Oxford Cancer & Haematology Centre
Oxford, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: WO45654 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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2024-516162-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
WO45654
Identifier Type: -
Identifier Source: org_study_id