A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) 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 assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rak piersi potwierdzony badaniem histologicznym lub cytologicznym, który jest miejscowo zaawansowany lub rozprzestrzeniony (przerzuty).
- •Rak piersi z dodatnimi receptorami estrogenowymi (ER+) i ujemnym receptorem HER2 (HER2-), potwierdzony według wytycznych.
- •Progresja choroby podczas lub po leczeniu innym lekiem (inhibitor CDK4/6) i leczeniem hormonalnym.
- •Choroba, którą można zmierzyć lub ocenić.
- •Ogólny stan zdrowia pacjentki pozwalający na aktywność (grupa 0 lub 1 wg skali ECOG).
- •Przewidywana długość życia co najmniej 6 miesięcy.
✗ Disqualifies
- •Zaawansowane objawy choroby w narządach wewnętrznych, które mogą prowadzić do poważnych powikłań zagrażających życiu w najbliższym czasie.
- •Przeszłość leczenia (poza badaniem) większą niż jedna linia terapii dla choroby zaawansowanej lub z przerzutami.
- •Wcześniejsze chemioterapia w leczeniu raka piersi z przerzutami.
- •Przyjmowanie niektórych leków hormonalnych lub inhibitorów CDK4/6 w ciągu ostatnich 7 lub 21 dni przed rozpoczęciem badania.
- •Problemy z wchłanianiem leków w przewodzie pokarmowym.
- •Inne choroby nowotworowe w ciągu ostatnich 3 lat (z pewnymi wyjątkami).
- •Znane uczulenie na którykolwiek ze składników badanych leków.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (61)
University of Arizona Cancer Center
Tucson, United States
City of Hope
Duarte, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, United States
UC San Diego Moores Cancer Center
La Jolla, United States
University of California San Diego Medical Center
San Diego, United States
UCSF Helen Diller Family CCC
San Francisco, United States
Sylvester Comprehensive Cancer Center
Miami, United States
Moffitt Cancer Center
Tampa, United States
Winship Cancer Institute of Emory University
Atlanta, United States
City of Hope® Cancer Center Chicago
Zion, United States
Barbara Ann Karmanos Cancer Institute
Detroit, United States
Maryland Oncology Hematology - Annapolis
Annapolis, United States
Washington University Siteman Cancer Center
St Louis, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States
New York Cancer & Blood Specialists
East Patchogue, United States
Montefiore Einstein Cancer Center
The Bronx, United States
Levine Cancer Institute
Charlotte, United States
Novant Health Cancer Institute
Charlotte, United States
Oncology Associates of Oregon, P.C
Eugene, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, United States
UPMC - Hillman Cancer Center
Pittsburgh, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, United States
Texas Oncology (Worth) - USOR
Dallas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, United States
Virginia Oncology Associates (Norfolk) - USOR
Norfolk, United States
St Vincent's Hospital Sydney
Darlinghurst, Australia
Cancer Research SA
Adelaide, Australia
Hospital do Cancer de Pernambuco - HCP
Recife, Brazil
ONCOSITE Centro de Pesquisa Clínica Em Oncologia
Ijuí, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Brazil
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
São Paulo, Brazil
Princess Margaret Hospital
Toronto, Canada
Shandong Cancer Hospital
Jinan, China
Fudan University Shanghai Cancer Center - Pudong Campus
Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Institut Jean Godinot
Reims, France
Gustave Roussy
Villejuif, France
Centre Francois Baclesse
Caen, France
Centre Oscar Lambret
Lille, France
Centre Eugene Marquis
Rennes, France
Universitatsklinikum Tubingen
Tübingen, Germany
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
Meldola, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Italy
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center.
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, Spain
Hospital Beata Maria Ana
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Trial contact
Reference Study ID Number: GO46021 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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