RecruitingPhase III🇵🇱 PolandEN original

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic 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 inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Ogólny stan zdrowia oceniony jako bardzo dobry lub dobry (ECOG 0-1)
  • Potwierdzony nowotwór piersi (rak gruczołowy) z przerzutami lub zaawansowany, nie nadający się do operacji
  • Potwierdzony wysokie stężenie białka HER2 w komórkach raka (wynik z badania centralnego)
  • Potwierdzana mutacja genu PIK3CA w komórkach raka (wynik z badania centralnego)
  • Co najmniej 6 miesięcy bez objawów choroby od ukończenia poprzedniego leczenia
  • Prawidłowa funkcja serca - frakcja wyrzutowa lewej komory co najmniej 50%
  • Prawidłowe wyniki badań krwi i funkcji narządów wewnętrznych

✗ Disqualifies

  • Poprzednie leczenie inhibitorami szlaków PI3K, AKT lub mTOR przy zaawansowanym raku
  • Poprzednie leczenie systemowe (innymi niż hormony) zaawansowanego HER2-dodatniego raka piersi
  • Zapalna choroba jelit (w przeszłości lub aktywna)
  • Pogorszenie się choroby w ciągu 6 miesięcy od poprzedniego leczenia na HER2
  • Cukrzyca typu 2 wymagająca leczenia lub historia cukrzycy typu 1
  • Aktywne zapalenie wątroby, marskość lub ciężkie uszkodzenie wątroby
  • Aktywna choroba płuc, zapalenie płuc lub śródmiąższowe zapalenie płuc
  • Historia rozprzestrzeniania się raka na opony mózgowe

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (192)

Banner Health MD Anderson AZ

Gilbert, United States

Disney Family Cancer Center

Burbank, United States

City of Hope

Corona, United States

City of Hope Comprehensive Cancer Center

Duarte, United States

City of Hope at Irvine Lennar

Irvine, United States

Ellison Institute of Technology

Los Angeles, United States

Georgetown Uni Hospital

Washington D.C., United States

Medstar Research Institute

Hyattsville, United States

Dana Farber Cancer Institute

Boston, United States

Henry Ford Hospital

Detroit, United States

Renown Regional Medical Center

Reno, United States

Hackensack University Medical Center

Hackensack, United States

Atrium Health

Charlotte, United States

Hightower Clinical

Oklahoma City, United States

Renovatio Clinical - El Paso

El Paso, United States

JPS Health Network

Fort Worth, United States

Lumi Research

Kingwood, United States

Renovatio Clinical

The Woodlands, United States

Kadlec Clinic Hematology and Oncology

Kennewick, United States

Swedish Medical Center

Seattle, United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Clínica Viedma

Viedma Rio Negro, Argentina

Blacktown Hospital

Blacktown, Australia

Kinghorn Cancer Centre

Darlinghurst, Australia

Gosford Hospital

Gosford, Australia

University of the Sunshine Coast

Sippy Downs, Australia

Monash Health

Clayton, Australia

Sir Charles Gairdner Hospital

Perth, Australia

Institut Jules Bordet

Anderlecht, Belgium

CHIREC

Auderghem, Belgium

CHU Brugmann (Victor Horta)

Brussels, Belgium

Cliniques Universitaires St-Luc

Brussels, Belgium

GHdC Site Les Viviers

Charleroi, Belgium

CHU HELORA - Hôpital de la Louvière - Site Jolimont

Haine-Saint-Paul, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

Clinique Ste-Elisabeth

Namur, Belgium

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Brazil

Hospital Sao Rafael - HSR

Salvador, Brazil

Hospital Araujo Jorge

Goiânia, Brazil

Hospital do Câncer de Londrina

Londrina, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Brazil

Hospital de Amor Amazônia

Porto Velho, 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

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Calgary, Canada

The Moncton Hospital

Moncton, Canada

Eastern Health - General Hospital

St. John's, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

Jewish General Hospital

Montreal, Canada

Hôpital du Sacré-Coeur de Montreal

Montreal, Canada

Centre Hospitalier de l?Université de Montréal (CHUM)

Montreal, Canada

Hopital du Saint Sacrement

Québec, Canada

Allan Blair Cancer Center

Regina, Canada

Affiliated Hospital of Hebei University

Baoding, China

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Sichuan Provincial Cancer Hospital

Chengdu, China

Sichuan Provincial People's Hospital

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Tumor Hospital

Harbin, China

Shandong Cancer Hospital

Jinan, China

The First Affiliated Hospital to Henan University of Science and Technology

Luoyang, China

The Second Affiliated Hospital to Nanchang University

Nanchang, China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, China

Shantou Center Hospital

Shantou, China

Tianjin Cancer Hospital

Tianjin, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Hubei Cancer Hospital

Wuhan, China

Clinica De La Costa

Barranquilla, Colombia

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogota, D.C., Colombia

Oncomedica S.A.

Montería, Colombia

Sociedad de Oncología y hematología del Cesar Ltda

Valledupar, Colombia

Tampere University Hospital

Tampere, Finland

Turku Uni Central Hospital

Turku, Finland

Institut Sainte Catherine

Avignon, France

Centre Hospitalier de La Cote Basque

Bayonne, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Centre Georges Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Klinikum St. Marien

Amberg, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Marienhospital Bottrop gGmbH

Bottrop, Germany

Gynonco Düsseldorf, MVZ Medical Center GmbH

Düsseldorf, Germany

Frauenarztpraxis Dr. Apel, Dr. Kolpin

Erfurt, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, Germany

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

München, Germany

St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren

Münster, Germany

Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

Saarbrücken, Germany

Gynäkologie Kompetenzzentrum

Stralsund, Germany

Universitätsfrauenklinik Ulm

Ulm, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Tuen Mun Hospital

Hong Kong, Hong Kong

Gujarat Cancer & Research Inst.

Ahmedabad, India

Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)

Surat, India

Artemis Hospital

Gurugram, India

Sir H. N. Reliance Foundation Hospital and Research Centre

Mumbai, India

National Cancer Institute

Nagpur, India

Max Super Speciality Hospital

NEW Delhi Delhi, India

Tata Medical Center

Kolkata, India

I.R.S.T Srl IRCCS

Meldola, Italy

Ospedale San Giovanni Addolorata

Rome, Italy

Ospedale San Raffaele

Milan, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Italy

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Italy

Ospedale San Gerardo

Monza, Italy

A.O.U. Maggiore della Carità

Novara, Italy

Casa di Cura La Maddalena

Palermo, Italy

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Italy

"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

Verona, Italy

Nagoya City University Hospital

Aichi, Japan

Chiba Cancer Center

Chiba, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Sagara Hospital

Kagoshima, Japan

Tokai University Hospital

Kanagawa, Japan

Kyoto University Hospital

Kyoto, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Saitama Medical University International Medical Center

Saitama, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

King Hussein Cancer Center

Amman, Jordan

University of Nairobi - Institute of Tropical and Infectious Diseases

Nairobi, Kenya

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

OncoMed

Mexico City, Mexico

Centro Oncológico Hematológico Roma

Mexico City, Mexico

Hospital Universitario

Monterrey, Mexico

CENEIT Oncologicos

Mexico City, Mexico

Sultan Qaboos Comprehensive Cancer Care & Research Center

Muscat, Oman

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Szpital Morski im.PCK

Gdynia, Poland

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, Poland

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, Poland

Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie

Późna, Poland

Centrum Onkologii Instytut im.M. Sklodowskiej-Curie

Warsaw, Poland

National University Hospital

Singapore, Singapore

National Cancer Centre

Singapore, Singapore

Icon Cancer Centre Farrer Park

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Hopelands Cancer Centre

Hilton, South Africa

Charlotte Maxeke Academic Hospital

Johannesburg, South Africa

Medical Oncology Centre of Rosebank

Johannesburg, South Africa

Limpopo Cancer Research Institute

Polokwane, South Africa

Steve Biko Academic Hospital

Pretoria, South Africa

Chris Hani Baragwanath Clinical Trial Site

Soweto, South Africa

National Cancer Center

Goyang-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

Seoul St Mary's Hospital

Seoul, South Korea

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Hospital Universitari Dexeus - Grupo Quironsalud

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

National Taiwan Uni Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital-Linkou

Taoyuan County, Taiwan

Abderrahmen Mami Hospital

Aryanah, Tunisia

Taher Maamouri Hospital

Nabeul, Tunisia

Habib Bourguiba Hospital

Sfax, Tunisia

Farhat Hached Hospital

Sousse, Tunisia

Institut Salah Azeiz

Tunis, Tunisia

Sakarya Training and Research Hospital

Adapazarı, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

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

Bakirkoy / Istanbul, Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

Medipol Mega Üniversite Hastanesi Göztepe

Istanbul, Turkey (Türkiye)

Izmir Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital

Sihhiye/Ankara, Turkey (Türkiye)

Uganda Cancer Institute

Kampala, Uganda

Belfast City Hospital

Belfast, United Kingdom

Blackpool Victoria Hospital

Blackpool, United Kingdom

Colchester General Hospital

Colchester, Essex, United Kingdom

Mount Vernon Hospital

Northwood, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Trial contact

Reference Study ID Number: WO44263 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.