To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
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
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony receptorowo-dodatni, HER2-ujemny nowotwór piersi
- •Pogorszenie stanu choroby mimo leczenia lub podczas leczenia połączeniem inhibitora CDK4/6 i hormonoterapii
- •Mierzalna lub ocenialna choroba wznowienia lub przerzutów
- •Lekarz uważa, że pacjent jest kandydatem do hormonoterapii, a chemioterapia nie jest wskazana
- •Potwierdzenie obecności mutacji PIK3CA
- •Spodziewana przeżywalność powyżej 6 miesięcy
- •Zdolność i chęć do uczestniczenia we wszystkich procedurach badania
✗ Disqualifies
- •Rak piersi typu metaplastycznego
- •Wcześniejsze leczenie chemioterapią wznowienia lub przerzutów
- •Cukrzyca typu 2 wymagająca aktualnego leczenia lub jakikolwiek epizod cukrzycy typu 1
- •Wcześniejsze leczenie inhibitorami PI3K/Akt/mTOR
- •Potrzeba codziennego uzupełniającego tlenu
- •Aktywna choroba płuc ze objawami, w tym zapalenie płuc
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (31)
Los Angeles Cancer Network
Los Angeles, United States
Cancer Specialists of North Florida
Jacksonville, United States
Astera Cancer Care East Brunswick
East Brunswick, United States
Instituto de Oncologia de Rosario
Rosario, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
Hospital Privado - Centro Medico de Córdoba
Córdoba, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
Centro Oncológico de Excelencia
San Juan, Argentina
Blacktown Hospital
Blacktown, Australia
Coffs Harbour Health Campus
Coffs Harbour, Australia
Bendigo Cancer Centre
Bendigo, Australia
Cliniques Universitaires St-Luc
Brussels, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Clinique Ste-Elisabeth
Namur, Belgium
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico
RENATI INNOVATION S.A.P.I. de C.V
Guadalajara, Mexico
Centro de Infusion Tratamiento e Investigacion Oncologica S DE R
Queretaro Qro, Mexico
CENEIT Oncologicos
Mexico City, Mexico
Hospital Universitari Vall d'Hebron;Oncology
Barcelona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Bagcilar Medipol Mega Universitesi Hastanesi
Bağcılar, Turkey (Türkiye)
Adana Baskent University Hospital
Adana, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, United Kingdom
Princess Alexandra Hospital
Harlow, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Trial contact
Reference Study ID Number: WO46063 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: 7/1/2026.
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