Actively Recruiting
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
Led by Genentech, Inc. · Updated on 2026-04-21
285
Participants Needed
35
Research Sites
151 weeks
Total Duration
On this page
Sponsors
G
Genentech, Inc.
Lead Sponsor
R
Roche (China) Holding Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic breast adenocarcinoma
- Tumor confirmed as ER+ and HER2- according to ASCO/CAP, ESMO, or equivalent guidelines
- Disease progressed during or after CDK4/6 inhibitor and approved endocrine therapy for advanced/metastatic disease
- Measurable or evaluable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months
You will not qualify if you...
- Advanced symptomatic visceral disease with risk of life-threatening complications requiring cytotoxic chemotherapy
- More than one prior line of therapy for locally advanced or metastatic breast cancer
- Prior chemotherapy for metastatic breast cancer
- Treatment with approved oral endocrine therapy within 7 days or fulvestrant/CDK4/6 inhibitor within 21 days before study drug start
- Malabsorption or gastrointestinal conditions affecting drug absorption
- History of other malignancy within 3 years except study cancer or low-risk cancers
- Known allergy or hypersensitivity to study treatments
AI-Screening
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Trial Site Locations
Total: 35 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
UCSF Helen Diller Family CCC
San Francisco, California, United States, 94158
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322-1013
Actively Recruiting
6
City of Hope® Cancer Center Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
7
Barbara Ann Karmanos Cancer Institute
Detroit, Maine, United States, 48201-2013
Actively Recruiting
8
Washington University Siteman Cancer Center
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
9
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901-1914
Actively Recruiting
10
New York Cancer & Blood Specialists
East Patchogue, New York, United States, 11772
Actively Recruiting
11
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213-3108
Actively Recruiting
13
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204-3609
Actively Recruiting
14
Texas Oncology (Worth) - USOR
Dallas, Texas, United States, 75246-2003
Actively Recruiting
15
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
16
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
17
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil, 50040-000
Actively Recruiting
18
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Actively Recruiting
19
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
20
Institut Jean Godinot
Reims, Champagne-Ardenne, France, 51100
Actively Recruiting
21
Gustave Roussy
Villejuif, Val-de-Marne, France, 94805
Actively Recruiting
22
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
23
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
24
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
25
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
26
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea, 6273
Actively Recruiting
27
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
28
Asan Medical Center.
Seoul, South Korea, 05505
Actively Recruiting
29
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
30
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
31
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, Spain, 08035
Actively Recruiting
32
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
33
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
34
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
35
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
R
Reference Study ID Number: GO46021 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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