A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
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 is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie lub cytologicznie rak piersi, który jest zaawansowany lub przerzutowy i nie można go operować ani leczyć promieniowaniem
- •Rak piersi dodatni w receptory hormonalne (HR+) i ujemny w receptor HER2
- •Potwierdzona mutacja genu PIK3CA w badaniu genetycznym
- •Choroba postępuje mimo leczenia kombinacją inhibitora CDK4/6 i hormonoterapii
- •Poprzednio otrzymano maksymalnie 2 linie chemioterapii przy chorobie przerzutowej
- •Widoczne lub możliwe do oceny zmiany nowotworowe
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-2)
- •Przewidywana długość życia dłuższa niż 6 miesięcy
✗ Disqualifies
- •Rzadka postać raka piersi (rak metaplazyjny)
- •Poprzednie leczenie inhibitorami PI3K, AKT lub mTOR w stadium zaawansowanym
- •Nawrót choroby ponad 12 miesięcy po zakończeniu adjuwantnej terapii CDK4/6, bez leczenia choroby przerzutowej
- •Cukrzyca typu 2 wymagająca leczenia lub jakikolwiek przypadek cukrzycy typu 1
- •Brak możliwości tolerowania badanego leczenia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 28, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (210)
Marin Cancer Care Inc
Greenbrae, United States
Cancer Blood and Specialty Clinic
Los Alamitos, United States
Los Angeles Cancer Network
Los Angeles, United States
University of California, Irvine Medical Center
Orange, United States
UC Davis Comprehensive Cancer Center
Sacramento, United States
Rocky Mountain Cancer Centers
Denver, United States
Banner MD Anderson Cancer Center
Greeley, United States
Eastern CT Hematology and Oncology Associates
Norwich, United States
Cancer Care Centers of Brevard
Palm Bay, United States
Cleveland Clinic Florida
Weston, United States
Grady Health System
Atlanta, United States
Midtown West Medical
Atlanta, United States
Emory University Hospital
Atlanta, United States
Winship Cancer Institute at Emory Saint Joseph's Hospital
Atlanta, United States
University of Louisville Hospital
Louisville, United States
Massachusetts General Hospital
Boston, United States
Karmanos Cancer Institute.
Detroit, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, United States
Minnesota Oncology Hematology
Saint Paul, United States
MD Anderson Cancer Center at Cooper
Camden, United States
Novant Health Presbyterain Medical Center
Charlotte, United States
Novant Health Forsyth Medical Center
Winston-Salem, United States
Gabrail Cancer Center
Canton, United States
Asante Rogue Regional Medical Center
Medford, United States
Bryn Mawr Hospital
Bryn Mawr, United States
St. Lukes Hospital and Health Network
Easton, United States
Paoli Memorial Hospital
Paoli, United States
Abramson Cancer Center Chester County Hospital
West Chester, United States
Lankenau Medical Center, Cancer Center
Wynnewood, United States
Main Line Health System
Wynnewood, United States
WellSpan Oncology Research
York, United States
Texas Oncology West
Amarillo, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, United States
Texas Tech University Health Sciences Center
El Paso, United States
Texas Oncology (Flower Mound) - USOR
Flower Mound, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, United States
Lumi Research
Kingwood, United States
Texas Oncology McKinney
McKinney, United States
Kadlec Clinic Hematology and Oncology
Kennewick, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer
La Rioja, Argentina
Instituto de Oncología de Rosario
Rosario, Argentina
Sanatorio Parque S.A.
Rosario, Argentina
Hosp Provincial D. Centenarios
Rosario, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, Argentina
Clinica Viedma S.A.
Viedma, Argentina
Campbelltown Hospital
Campbelltown, Australia
Coffs Harbour Health Campus
Coffs Harbour, Australia
Concord Repatriation General Hospital
Concord, Australia
Kinghorn Cancer Centre
Darlinghurst, Australia
Gosford Hospital
Gosford, Australia
Icon Cancer Care Wesley
Auchenflower, Australia
University of the Sunshine Coast
Sippy Downs, Australia
Bendigo Cancer Centre
Bendigo, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Cliniques Universitaires St-Luc
Brussels, Belgium
GHdC Site Les Viviers
Charleroi, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Clinique Ste-Elisabeth
Namur, Belgium
Hospital da Bahia
Salvador, Brazil
Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR
Brasília, Brazil
NUPEC
Belo Horizonte, Brazil
Hospital Santa Cruz / Centro de Oncologia D'Or
Curitiba, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Brazil
Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife
Recife, Brazil
Vencer Oncoclínica - Centro de Pesquisa do Piauí
Teresina, Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, Brazil
Hospital Sírio-Libanês
São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Canada
Cross Cancer Institute
Edmonton, Canada
BC Cancer ? Vancouver
Vancouver, Canada
The Moncton Hospital
Moncton, Canada
Juravinski Hospital
Hamilton, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Canada
Jewish General Hospital
Montreal, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Canada
The First Hospital of Jilin University
Changchun, China
Sichuan Provincial Cancer Hospital
Chengdu, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China
Sun yat-sen University Cancer Center
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, China
Harbin Medical University Tumor Hospital
Harbin, China
Shandong Cancer Hospital
Jinan, China
The Second Affiliated Hospital to Nanchang University
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, China
Tianjin Cancer Hospital
Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China
Zhejiang Cancer Hospital
Zhejiang, China
Institut Sainte Catherine
Avignon, France
Centre Hospitalier de La Cote Basque
Bayonne, France
Polyclinique Bordeaux Nord
Bordeaux, France
Centre Leon Berard
Lyon, France
ICM
Montpellier, France
Centre Eugene Marquis
Rennes, France
IUCT Oncopole
Toulouse, France
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin
Aachen, Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany
Universitätsklinikum Essen
Essen, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, Germany
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, Germany
MVZ für Hämatologie und Onkologie Ravensburg GmBH
Ravensburg, Germany
A.O. S. Anna e San Sebastiano
Caserta, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Italy
AUSL della Romagna
Ravenna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Italy
Ospedale San Raffaele
Milan, Italy
ASL AL - Azienda Sanitaria Locale AL
Alessandria, Italy
AOU Città della Salute e della Scienza di Torino
Turin, Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Italy
Ospedale Di Macerata
Province of Macerata, Italy
Ospedale Santa Chiara
Trento, Italy
Ospedale S. Giuseppe
Empoli (FI), Italy
Panamerican Clinical Research S.A de C.V.
Guadalajara, Mexico
RENATI INNOVATION S.A.P.I. de C.V
Guadalajara, Mexico
COI Centro Oncologico Internacional Santa Fe
Mexico City, Mexico
Health Pharma Professional Research
Mexico City, Mexico
OncoMed
Mexico City, Mexico
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, Mexico
Instituto Nacional de Cancerologia
Distrito Federal, Mexico
CENEIT Oncologicos
Mexico City, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Morelia, Mexico
New Zealand Clinical Research - Auckland
Auckland, New Zealand
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, 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
Szpital Uniwersytecki w Krakowie
Krakow, Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
Warsaw, Poland
Dr. W.M. Szpak Incorporated trading as Rainbow Oncology
Durban, South Africa
Hopelands Cancer Centre
Hilton, South Africa
Medical Oncology Centre of Rosebank
Johannesburg, South Africa
Richards Bay Oncology Centre
KwaZulu Natal, South Africa
Mountain View Oncology
Paarl, South Africa
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Korea University Anam Hospital
Seoul, 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
ICO L'Hospitalet
L'Hospitalet de Llobregat, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital San Pedro De Alcantara
Cáceres, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
Hospital Universitario Virgen de Arrixaca
Murcia, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hosipital at Linkou
Taoyuan City, Taiwan
Veterans General Hospital - Taichung
Xitun Dist., Taiwan
National Taiwan University Hospital
Zhongzheng Dist., Taiwan
Chulalongkorn Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Chulabhorn Hospital
Lak Si, Thailand
Songklanagarind Hospital
Songkhla, Thailand
Gulhane Training and Applicaton Hospital
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, Turkey (Türkiye)
Marmara Uni Faculty of Medicine
Istanbul, Turkey (Türkiye)
Ege Uni Medical Faculty Hospital
Izmir, Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, Turkey (Türkiye)
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Princess Alexandra Hospital
Harlow, United Kingdom
St John's Hospital
Livingston, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Maidstone & Tonbridge Wells Hospital
Maidstone, United Kingdom
Mount Vernon & Watford Hospital Trust
Northwood, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Royal Preston Hosptial
Preston, United Kingdom
Royal Hampshire County Hospital
Winchester, United Kingdom
Trial contact
Reference Study ID Number: WO43919 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.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/2/2026.
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