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
Start Date
10/7/2025
Completion Date
8/31/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
GDC-4198
Giredestrant
Abemaciclib
Conditions
Locations
City of Hope
Duarte, California 91010
United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California 92618
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093-1503
United States
UCSF Helen Diller Family CCC
San Francisco, California 94158
United States
Sylvester Comprehensive Cancer Center
Miami, Florida 33136-1002
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322-1013
United States
City of Hope® Cancer Center Chicago
Zion, Illinois 60099
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Maine 48201-2013
United States
Washington University Siteman Cancer Center
St Louis, Missouri 63110-1010
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901-1914
United States
New York Cancer & Blood Specialists
East Patchogue, New York 11772
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Novant Health Cancer Institute
Charlotte, North Carolina 28204
United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania 15213-3108
United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204-3609
United States
Texas Oncology (Worth) - USOR
Dallas, Texas 75246-2003
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84013
United States
Virginia Oncology Associates (Norfolk) - USOR
Norfolk, Virginia 23502-2800
United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
Australia
Cancer Research SA
Adelaide, South Australia 5000
Australia
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco 50040-000
Brazil
ONCOSITE Centro de Pesquisa Clínica Em Oncologia
Ijuí, Rio Grande do Sul 98700-000
Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-074
Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul 90560-030
Brazil
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
São Paulo, 01246-000
Brazil
Princess Margaret Hospital
Toronto, Ontario M5G 2M9
Canada
Shandong Cancer Hospital
Jinan, SD 250117
China
Fudan University Shanghai Cancer Center - Pudong Campus
Shanghai, Shanghai Municipality 201321
China
Institut Jean Godinot
Reims, Champagne-Ardenne 51100
France
Gustave Roussy
Villejuif, Val-de-Marne 94805
France
Centre Francois Baclesse
Caen, 14076
France
Centre Oscar Lambret
Lille, 59020
France
Centre Eugene Marquis
Rennes, 35042
France
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia 45136
Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20251
Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna 40138
Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
Meldola, Emilia-Romagna 47014
Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardy 25123
Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy 20132
Italy
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi 6273
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center.
Seoul, 05505
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
South Korea
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 08035
Spain
Hospital Beata Maria Ana
Madrid, 28007
Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain