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NCT06790693PHASE3Recruiting

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

Hoffmann-La Roche

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

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

Interventions

DRUG

Inavolisib

DRUG

Placebo

DRUG

CDK4/6i

DRUG

Letrozole

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Conditions

Breast Cancer

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