AzTrials
AzTrials

Breast CancerPhase 3INAVO123NCT06790693

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

A Phase 3 study testing Inavolisib, CDK4/6i and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 242 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Inavolisib, CDK4/6i and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
242 sitesin 20 countries
Study dates
9 Apr 2025to 1 Feb 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

242 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

242 sites in 20 countries

United States62 sites, 62 recruiting

  • Velocity Clinical Research

    Annapolis, Maryland, 21401

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Recruiting

  • Disney Family Cancer Center

    Burbank, California, 91505

    Recruiting

  • Novant Health Cancer Institute

    Charlotte, North Carolina, 28204

    Recruiting

  • Fairview Hospital

    Cleveland, Ohio, 44111

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44915

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Recruiting

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816

    Recruiting

  • Swedish Cancer Institute - Edmonds Campus

    Edmonds, Washington, 98026

    Recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201-1621

    Recruiting

  • Summit Medical Group

    Florham Park, New Jersey, 07932

    Recruiting

  • JPS Health Network

    Fort Worth, Texas, 76104

    Recruiting

  • West Cancer Center

    Germantown, Tennessee, 38138

    Recruiting

  • City of Hope - Phoenix

    Goodyear, Arizona, 85338

    Recruiting

  • Nebraska Cancer Specialists

    Grand Island, Nebraska, 68803

    Recruiting

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

    Recruiting

  • Bon Secours - St. Francis Hospital

    Greenville, South Carolina, 29607

    Recruiting

  • City of Hope - Lennar Foundation Cancer Center

    Irvine, California, 92618

    Recruiting

  • Cancer Specialists of North Florida - Jacksonville

    Jacksonville, Florida, 32207

    Recruiting

  • HCA Midwest Health

    Kansas City, Missouri, 64132

    Recruiting

  • Scripps Health

    La Jolla, California, 92040

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Recruiting

  • Baptist Health Hamburg

    Lexington, Kentucky, 40509

    Recruiting

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky, 40536

    Recruiting

  • City Of Hope

    Long Beach, California, 90813

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Recruiting

  • Ellison Medical Institute

    Los Angeles, California, 90064

    Recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Recruiting

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Recruiting

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060

    Recruiting

  • Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

    Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

    Recruiting

  • The Blavatnik Family ? Chelsea Medical Center at Mount Sinai

    New York, New York, 10011

    Recruiting

  • Mount Sinai West

    New York, New York, 10019

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Cancer Care Specialists of Central Illinois

    O'Fallon, Illinois, 62269

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

    Recruiting

  • Palo Alto Medical Foundation Research Center

    Palo Alto, California, 94301

    Recruiting

  • The Dignity Health Cancer Institute

    Phoenix, Arizona, 85004

    Recruiting

  • UPMC Hillman Cancer Center - Magee-Women?s Hospital

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Recruiting

  • Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services Pharmacy

    Portland, Oregon, 97225

    Recruiting

  • Huntsman Cancer Hospital at the University of Utah

    Salt Lake City, Utah, 84113

    Recruiting

  • Kaiser Permanente - San Marcos

    San Marcos, California, 92069

    Recruiting

  • Palo Alto Medical Foundation Research Center

    San Mateo, California, 94401

    Recruiting

  • Swedish Cancer Institute - Issaquah

    Seattle, Washington, 98104

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • New York Cancer & Blood Specialists

    Shirley, New York, 11967

    Recruiting

  • Community Clinical Trials

    Spring, Texas, 77389

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Recruiting

  • Palo Alto Medical Foundation Research Center

    Sunnyvale, California, 94086

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Recruiting

  • Tallahassee Memorial HealthCare

    Tallahassee, Florida, 32308

    Recruiting

  • Moffitt Cancer Center-McKinley Campus

    Tampa, Florida, 33612

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Recruiting

  • Novant Health Cancer Institute

    Winston-Salem, North Carolina, 27103

    Recruiting

  • City of Hope® Cancer Center Chicago

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

China20 sites, 20 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100032

    Recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

    Recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, 510060

    Recruiting

  • Sun Yat-Sen University Cancer Center - Huangpu Campus

    Guangzhou

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, 529030

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Recruiting

  • Jinhua municipal central hospital

    Jinhua, 321083

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, 650118

    Recruiting

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Shantou Center Hospital

    Shantou, 515031

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, 300000

    Recruiting

  • Tianjin Cancer hospital Airport hospital

    Tianjin, 300300

    Recruiting

  • Xinjiang Medical University Cancer Hospital

    Ürümqi, 830011

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, 710004

    Recruiting

  • Shanxi Provincial People's Hospital

    Xi'an, 710068

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441106

    Recruiting

Other trials in China

Italy17 sites, 17 recruiting

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

    Recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

    Recruiting

  • Azienda Sanitaria dell'Alto Adige;U.O.C. Oncologia Medic

    Bolzano, Trentino-Alto Adige, 39100

    Recruiting

  • A.O. S. Anna e San Sebastiano

    Caserta, Campania, 81100

    Recruiting

  • Ospedale Civile - Livorno

    Livorno, Tuscany, 57124

    Recruiting

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

    Recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

    Recruiting

  • Humanitas Centro Catanese Di Oncologia

    Misterbianco (CT), Sicily, 95045

    Recruiting

  • A.O. Universitaria Policlinico Di Modena

    Modena, Emilia-Romagna, 41100

    Recruiting

  • A.O. Universitaria Federico II Di Napoli

    Naples, Campania, 80131

    Recruiting

  • U.O.C. Oncologia Medica Senologica

    Naples, Campania, 80131

    Recruiting

  • University of Eastern Piedmont - Maggiore della Carità University Hospital

    Novara, Umbria, 28100

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    Recruiting

  • A.O. Santa Maria Terni

    Terni, Umbria, 05100

    Recruiting

  • Az. Osp. G. Panico

    Tricase (LE), Apulia, 73039

    Recruiting

Other trials in Italy

Germany15 sites, 14 recruiting

  • St. Elisabeth Krankenhaus Köln GmbH

    Cologne, 50935

    Recruiting

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

    Recruiting

  • Universitätsklinikum Essen

    Essen, 45122

    Recruiting

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

    Essen, 45136

    Recruiting

  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

    Hamburg, 20357

    Recruiting

  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

    Hanover, 30625

    Recruiting

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

    Recruiting

  • InVO - Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

    Recruiting

  • Dres. Andreas Köhler und Roswitha Fuchs

    Langen, 63225

    Recruiting

  • Universitätsklinikum Münster

    Münster, 48149

    Recruiting

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

    Recruiting

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

    Recruiting

  • Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

    Saarbrücken, 66113

    Withdrawn

  • Universitätsklinik Tübingen

    Tübingen, 72076

    Recruiting

  • Universitätsklinikum Ulm Am Michelsberg

    Ulm, 89075

    Recruiting

Other trials in Germany

Spain15 sites, 15 recruiting

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

    Recruiting

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

    Recruiting

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

    Recruiting

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006

    Recruiting

  • IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica

    Madrid, 28007

    Recruiting

  • Hospital General Univ. Gregorio Maranon

    Madrid, 28009

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

    Recruiting

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

    Recruiting

  • Hospital Clinico Universitario Virgen de la Victoria;Servicio de Oncologia

    Málaga, 29011

    Recruiting

  • Hospital de Navarra

    Pamplona/iruña, Navarre, 31008

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

Brazil13 sites, 13 recruiting

  • Centro de Oncologia de Alfenas

    Alfenas, Minas Gerais, 37130-087

    Recruiting

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

    Recruiting

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-232

    Recruiting

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070

    Recruiting

  • Hospital do Câncer de Londrina

    Londrina, Paraná, 86015-520

    Recruiting

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

    Recruiting

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

    Recruiting

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120

    Recruiting

  • Obras Sociais Irma Dulce - Osid

    Salvador, Estado de Bahia, 40415-006

    Recruiting

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

    Recruiting

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001

    Recruiting

  • Vencer Oncoclínica - Centro de Pesquisa do Piauí

    Teresina, Piauí, 64049-200

    Recruiting

  • Hospital Santa Rita de Cassia Vitoria

    Vitória, Espírito Santo, 29043-260

    Recruiting

Other trials in Brazil

Canada12 sites, 12 recruiting

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary, Alberta, T2N 4C2

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

    Recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C1

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Hôpital du Sacré-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

    Recruiting

  • The Ottawa Hospital Cancer Center

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Unité de Recherche Clinique du CISSS de Laurentides

    Saint-Jérôme, Quebec, J7Z 2V4

    Recruiting

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Recruiting

  • St. Joseph's Health Centre

    Toronto, Ontario, M6R 1B5

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Recruiting

Other trials in Canada

France12 sites, 12 recruiting

  • ICO Paul Papin

    Angers, 49055

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Recruiting

  • Centre Cancerologie Grand Montpellier

    Montpellier, 34070

    Recruiting

  • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

    Paris, 75005

    Recruiting

  • Centre CARIO - HPCA

    Plérin, 22190

    Recruiting

  • Chu La Miletrie

    Poitiers, 86021

    Recruiting

  • Centre Eugene Marquis

    Rennes, 35042

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Recruiting

  • HOPITAL RENE HUGUENIN- Institut Curie

    Saint-Cloud, 92211

    Recruiting

  • Ico Rene Gauducheau

    Saint-Herblain, 44805

    Recruiting

  • Institut Universitaire de Cancer de Toulouse Oncopole

    Toulouse, 31100

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Japan10 sites, 10 recruiting

  • Aichi Cancer Center

    Aichi, 464-8681

    Recruiting

  • Chiba Cancer Center

    Chiba, 260-8717

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Recruiting

  • Hokkaido University Hospital

    Hokkaido, 060-8648

    Recruiting

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

    Recruiting

  • Tokai University Hospital

    Kanagawa, 259-1193

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Recruiting

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

    Recruiting

  • The Cancer Inst. Hosp. of JFCR

    Tokyo, 135-8550

    Recruiting

Other trials in Japan

Poland10 sites, 9 recruiting

  • Instytut "Centrum Zdrowia Matki Polki"

    ?ód?, 93-338

    Recruiting

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

    Recruiting

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

    Recruiting

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581

    Recruiting

  • Szpital Miejski Specjalistyczny Narutowicza

    Krakow, 31-202

    Withdrawn

  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

    Lublin, 20-090

    Recruiting

  • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie

    Późna, 61-866

    Recruiting

  • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

    Rzeszów, 35-021

    Recruiting

  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

    Warsaw, 02-781

    Recruiting

  • Dolno?l?skie Centrum Onkologii

    Wroc?aw, 53-413

    Recruiting

Other trials in Poland

South Korea9 sites, 9 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Recruiting

  • Soon Chun Hyang University Cheonan Hospital

    Dongnam-gu, Cheonan-si, 31151

    Recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

United Kingdom9 sites, 9 recruiting

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

    Recruiting

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

    Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • Princess Alexandra Hospital

    Harlow, CM20 1QX

    Recruiting

  • St Bartholomew's Hospital

    London, EC1M 6BQ

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Recruiting

  • Mount Vernon & Watford Hospital Trust

    Northwood, HA6 2RN

    Recruiting

  • Churchill Hospital - Oxford Cancer & Haematology Centre

    Oxford, OX3 7LE

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SJ

    Recruiting

Other trials in United Kingdom

Mexico8 sites, 8 recruiting

  • Centro Estatal de Cancerologia de Chihuahua

    Chihuahua City, 31000

    Recruiting

  • Centro de Investigacion y Tratamiento Integral del Cancer: CITI Cancer Oaxaca S.A de C.V.

    Ciudad de Huajuapan de León, Oaxaca, 69007

    Recruiting

  • Iem-Fucam

    D.F., 04980

    Recruiting

  • Instituto Nacional De Cancerologia

    Distrito Federal, Mexico CITY (federal District), 14000

    Recruiting

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

    Recruiting

  • Hospital General de Mexico

    MexicoCiudad de México, Nuevo León, 6726

    Recruiting

  • Hospital Zambrano Hellion TecSalud

    Monterrey, Nuevo León

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

    Recruiting

Other trials in Mexico

Taiwan6 sites, 6 recruiting

  • Chia-Yi Christian Hospital

    Chiayi City, 600566

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Recruiting

  • National Cheng Kung Uni Hospital

    Tainan, 704

    Recruiting

  • National Taiwan Uni Hospital

    Taipei, 100

    Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112019

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)6 sites, 6 recruiting

  • Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Ankara City Hospital

    Ankara, 06800

    Recruiting

  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

    Bakirkoy / Istanbul, 34147

    Recruiting

  • Ba?c?lar Medipol Mega Üniversite Hastanesi

    Istanbul, 34214

    Recruiting

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360

    Recruiting

  • Mersin City Education and Research Hospital

    Mersin, 33240

    Recruiting

Other trials in Turkey (Türkiye)

Argentina5 sites, 5 recruiting

  • Centro Oncologico Korben

    Caba, C1426AGE

    Recruiting

  • Centro Médico Fleischer

    Capital Federal, C1414

    Recruiting

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, 5016

    Recruiting

  • Instituto de Oncologia de Rosario

    Rosario, S2013KZE

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  • Centro Oncológico de Excelencia

    San Juan, J5400

    Recruiting

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Australia5 sites, 5 recruiting

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

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  • Monash Health

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  • Lyell McEwin Hospital

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  • Maroondah hospital;Oncology clinical trials

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  • Royal North Shore Hospital

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Switzerland4 sites, 4 recruiting

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  • CHUV

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South Africa3 sites, 2 recruiting

  • Linksfield Oncology Inc.

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Puerto Rico1 site, 1 recruiting

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Other trials in Puerto Rico

About this study

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

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).

Conditions
Breast Cancer
Being tested
Inavolisib, Placebo, CDK4/6i, Letrozole
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    Also called GDC-0077, Itovebi

    Participants will receive oral inavolisib once daily (QD).

  • PlaceboDrug

    Participants will receive oral placebo QD.

  • CDK4/6iDrug

    Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.

  • LetrozoleDrug

    Participants will receive oral letrozole QD.

Study groups in NCT06790693
Study groupRoleWhat they receive
Inavolisib + Letrozole + CDK4/6iExperimentalParticipants will receive inavolisib, letrozole and CDK4/6i.
Receives: Drug: Inavolisib; Drug: CDK4/6i; Drug: Letrozole
Placebo + Letrozole + CDK4/6iPlacebo comparatorParticipants will receive placebo, letrozole and CDK4/6i.
Receives: Drug: Placebo; Drug: CDK4/6i; Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)

Secondary outcomes (13)

  1. Overall Survival (OS)

    Measured: From randomization to death from any cause (up to 7 years)

  2. Investigator-assessed Objective Response Rate (ORR)

    Measured: Up to 7 years

  3. Investigator-assessed Duration of Response (DOR)

    Measured: 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)

  4. Investigator-assessed Clinical Benefit Rate (CBR)

    Measured: Up to 7 years

  5. Time to Confirmed Deterioration (TTCD) in Pain

    Measured: From baseline until end of follow-up (up to 7 years)

  6. TTCD in Physical Function

    Measured: From baseline until end of follow-up (up to 7 years)

  7. TTCD in Role Function

    Measured: From baseline until end of follow-up (up to 7 years)

  8. TTCD in Global Health Status

    Measured: From baseline until end of follow-up (up to 7 years)

  9. Percentage of Participants with Adverse Events

    Measured: From baseline until end of follow-up (up to 7 years)

  10. 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)

    Measured: Up to 7 years

  11. 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)

    Measured: Up to 7 years

  12. Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE

    Measured: Baseline up to 7 years

  13. Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item

    Measured: Baseline up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start9 Apr 2025
  3. Primary completion31 Jan 2032 (estimated)
  4. Study completion1 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790693
Sponsor's protocol ID
WO45654
Other IDs
2024-516162-11-00
Acronym
INAVO123
Status last verified
Nov 2026
First submitted
14 Jan 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inavolisib, CDK4/6i and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 242 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 242 sites in United States, China, Italy, Germany, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06790693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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