RecruitingPhase III🇵🇱 PolandEN original

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobieta lub mężczyzna z potwierdzonym rakiem piersi
  • Guz dodatni do receptorów hormonalnych (ER i/lub progesteron)
  • Guz ujemny dla receptora HER2
  • Nowy przypadek raka lub nawrót po co najmniej 2 latach leczenia hormonalnego bez pogorszenia choroby
  • Możliwość wykazania zmian mierzalnych w badaniach obrazowych
  • Ogólny stan zdrowia: 0 lub 1 w skali ECOG
  • Prawidłowe wyniki morfologii krwi i funkcji organów
  • Zgoda na dostarczenie próbki guza do badań

✗ Disqualifies

  • Ciąża, karmienie piersią lub planowanie ciąży podczas badania
  • Rzadki typ raka piersi (rak metaplazji)
  • Wcześniejsze leczenie systemowe raka piersi z przerzutami
  • Cukrzyca typu 2 wymagająca leczenia lub dowolna historia cukrzycy typu 1
  • Historia zapalenia opon mózgowych spowodowanego rakiem
  • Nielechane lub aktywne przerzuty w mózgu
  • Aktywne zapalenie lub infekcja oczu, historia zapalenia błony naczyniowej oka
  • Aktywna choroba płuc ze objawami

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 2, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (232)

The Dignity Health Cancer Institute

Phoenix, United States

Disney Family Cancer Center

Burbank, United States

Scripps Health

La Jolla, United States

Cancer and Blood Specialty Clinic

Los Alamitos, United States

Ellison Institute of Technology

Los Angeles, United States

Palo Alto Medical Foundation Research Center

Palo Alto, United States

Kaiser Permanente - San Marcos

San Marcos, United States

Palo Alto Medical Foundation Research Center

San Mateo, United States

Palo Alto Medical Foundation Research Center

Sunnyvale, United States

Cancer Specialists of North Florida - Jacksonville

Jacksonville, United States

Tallahassee Memorial HealthCare

Tallahassee, United States

Moffitt Cancer Center-McKinley Campus

Tampa, United States

Cleveland Clinic Florida

Weston, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, United States

Cancer Care Specialists of Central Illinois

O'Fallon, United States

Springfield Clinic

Springfield, United States

Carle Cancer Center

Urbana, United States

Baptist Health Lexington

Lexington, United States

Baptist Health Hamburg

Lexington, United States

University of Kentucky - Markey Cancer Center

Lexington, United States

University of Louisville Hospital

Louisville, United States

Baptist Health Louisville

Louisville, United States

Velocity Clinical Research

Annapolis, United States

University of Maryland

Baltimore, United States

Henry Ford Health System

Detroit, United States

Cancer & Hematology Centers of Western Michigan

Grand Rapids, United States

University of Minnesota Medical Center

Minneapolis, United States

HCA Midwest Health

Kansas City, United States

Nebraska Cancer Specialists

Grand Island, United States

Nebraska Cancer Specialists

Omaha, United States

Astera Cancer Care East Brunswick

East Brunswick, United States

Summit Medical Group

Florham Park, United States

The Blavatnik Family ? Chelsea Medical Center at Mount Sinai

New York, United States

Mount Sinai West

New York, United States

Icahn School of Medicine at Mount Sinai

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Duke Cancer Institute

Durham, United States

Fairview Hospital

Cleveland, United States

Cleveland Clinic Foundation

Cleveland, United States

Hillcrest Hospital

Mayfield Heights, United States

Providence Portland Medical Center

Portland, United States

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

Portland, United States

UPMC Hillman Cancer Center - Magee-Women?s Hospital

Pittsburgh, United States

Bon Secours - St. Francis Hospital

Greenville, United States

West Cancer Center

Germantown, United States

Vanderbilt University Medical Center

Nashville, United States

JPS Health Network

Fort Worth, United States

Community Clinical Trials

Kingwood, United States

Huntsman Cancer Hospital at the University of Utah

Salt Lake City, United States

Swedish Cancer Institute - Edmonds Campus

Edmonds, United States

Providence Regional Cancer Partnership

Everett, United States

Swedish Cancer Institute - Issaquah

Seattle, United States

Swedish Cancer Institute

Seattle, United States

Northwest Medical Specialties

Tacoma, 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

Blacktown Hospital

Blacktown, Australia

Royal North Shore Hospital

St Leonards, Australia

Lyell McEwin Hospital

Elizabeth Vale, Australia

Maroondah hospital;Oncology clinical trials

Ringwood, Australia

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Brazil

Hospital Santa Rita de Cassia Vitoria

Vitória, Brazil

Obras Sociais Irma Dulce - Osid

Salvador, Brazil

Hospital Araujo Jorge

Goiânia, Brazil

Centro de Oncologia de Alfenas

Alfenas, Brazil

Hospital do Câncer de Londrina

Londrina, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Brazil

Vencer Oncoclínica - Centro de Pesquisa do Piauí

Teresina, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital de Cancer de Barretos

Barretos, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, Brazil

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

São Paulo, Brazil

Instituto Nacional de Cancer - INCa

Rio de Janeiro, Brazil

Arthur J.E. Child Comprehensive Cancer Center

Calgary, Canada

Cross Cancer Institute

Edmonton, Canada

CancerCare Manitoba

Winnipeg, Canada

The Moncton Hospital

Moncton, Canada

The Ottawa Hospital Cancer Center

Ottawa, Canada

Sault Area Hospital

Sault Ste. Marie, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

St. Joseph's Health Centre

Toronto, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Canada

Jewish General Hospital

Montreal, Canada

Hôpital du Sacré-Coeur de Montreal

Montreal, Canada

Unité de Recherche Clinique du CISSS de Laurentides

Saint-Jérôme, Canada

Xiangyang Central Hospital

Xiangyang, 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

ICO Paul Papin

Angers, France

Centre Oscar Lambret

Lille, France

Centre Cancerologie Grand Montpellier

Montpellier, France

INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

Paris, France

Centre CARIO - HPCA

Plérin, France

Chu La Miletrie

Poitiers, France

Centre Eugene Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

HOPITAL RENE HUGUENIN- Institut Curie

Saint-Cloud, France

Ico Rene Gauducheau

Saint-Herblain, France

Institut Universitaire de Cancer de Toulouse Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

St. Elisabeth Krankenhaus Köln GmbH

Cologne, Germany

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 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

Klinikum Ernst von Bergmann

Potsdam, 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), Italy

A.O. S. Anna e San Sebastiano

Caserta, Italy

A.O. Universitaria Federico II Di Napoli

Naples, Italy

U.O.C. Oncologia Medica Senologica

Naples, Italy

Policlinico S.Orsola-Malpighi

Bologna, Italy

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

Meldola, Italy

A.O. Universitaria Policlinico Di Modena

Modena, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Asst Papa Giovanni XXIII

Bergamo, Italy

Ospedale San Raffaele

Milan, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Italy

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

Bolzano, Italy

Ospedale Civile - Livorno

Livorno, Italy

University of Eastern Piedmont - Maggiore della Carità University Hospital

Novara, Italy

A.O. Santa Maria Terni

Terni, Italy

Chiba Cancer Center

Chiba, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Hiroshima University Hospital

Hiroshima, Japan

Hokkaido University Hospital

Hokkaido, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Tokai University Hospital

Kanagawa, Japan

Okayama University Hospital

Okayama, Japan

Saitama Medical University International Medical Center

Saitama, Japan

The Cancer Inst. Hosp. of JFCR

Tokyo, Japan

Instituto Nacional De Cancerologia

Distrito Federal, Mexico

Hospital General de Mexico

MexicoCiudad de México, Mexico

Hospital Zambrano Hellion TecSalud

Monterrey, Mexico

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

Ciudad de Huajuapan de León, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 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

Dolno?l?skie Centrum Onkologii

Wroc?aw, 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, Spain

ICO L'Hospitalet

L'Hospitalet de Llobregat, Spain

Hospital de Navarra

Pamplona/iruña, Spain

Hospital de Basurto

Bilbao, Spain

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

Barcelona, Spain

Hospital Universitario de la Princesa

Madrid, Spain

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

Madrid, Spain

Hospital General Univ. Gregorio Maranon

Madrid, Spain

Hospital Universitario Infanta Leonor

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

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Kantonsspital Baden Zentrum für Onkologie und Hämatologie

Baden, Switzerland

Universitätsspital Basel

Basel, Switzerland

CHUV

Lausanne, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

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)

Izmir Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Mersin City Education and Research Hospital

Mersin, Turkey (Türkiye)

Blackpool Victoria Hospital

Blackpool, United Kingdom

Colchester General Hospital

Colchester, Essex, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Princess Alexandra Hospital

Harlow, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

Royal Free Hospital

London, United Kingdom

Mount Vernon & Watford Hospital Trust

Northwood, United Kingdom

Churchill Hospital - Oxford Cancer & Haematology Centre

Oxford, United Kingdom

Weston Park Hospital

Sheffield, United Kingdom

Trial contact

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

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

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.