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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
Sponsor: Genentech, Inc.
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.
Official title: A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
285
Start Date
2025-10-07
Completion Date
2028-08-31
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
GDC-4198
GDC-4198 will be administered orally.
Giredestrant
Giredestrant will be administered orally.
Abemaciclib
Abemaciclib will be administered orally.
Locations (39)
City of Hope
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UCSF Helen Diller Family CCC
San Francisco, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
City of Hope® Cancer Center Chicago
Zion, Illinois, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Maine, United States
Washington University Siteman Cancer Center
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York Cancer & Blood Specialists
East Patchogue, New York, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
Texas Oncology (Worth) - USOR
Dallas, Texas, United States
Virginia Oncology Associates (Norfolk) - USOR
Norfolk, Virginia, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, Brazil
Princess Margaret Hospital
Toronto, Ontario, Canada
Institut Jean Godinot
Reims, Champagne-Ardenne, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Centre Francois Baclesse
Caen, France
Centre Oscar Lambret
Lille, France
Centre Eugene Marquis
Rennes, France
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia, Germany
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardy, Italy
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center.
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
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