Actively Recruiting
A Phase Ib/II Study Comparing GDC-4198 Alone and With Giredestrant Versus Abemaciclib and Giredestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer
Led by Genentech, Inc. · Updated on 2026-05-18
285
Participants Needed
39
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of the drug GDC-4198 alone and combined with giredestrant compared to abemaciclib plus giredestrant in people with locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The study includes two phases: Phase Ib focuses on safety and how the body processes GDC-4198 alone and with giredestrant, while Phase II compares the activity and safety of GDC-4198 plus giredestrant against abemaciclib plus giredestrant. Participants have previously experienced disease progression during or after treatment with a CDK4/6 inhibitor and endocrine therapy. Participants receive treatments orally in 28-day cycles until unacceptable side effects, disease progression, or loss of clinical benefit. In Phase Ib, GDC-4198 is given alone or combined with giredestrant at varying doses. In Phase II, participants are randomly assigned to receive GDC-4198 with giredestrant at higher or lower doses, or abemaciclib with giredestrant. Dosing is daily, with abemaciclib taken twice daily at 150 mg. Participants will be monitored for up to 36 months, with assessments including safety evaluations, measuring side effects, disease progression, response rates, duration of response, overall survival, and drug concentrations in the blood. Researchers will track adverse events, dose-limiting toxicities, and progression-free survival. Study visits will include physical exams, laboratory tests, and imaging to evaluate tumor status and treatment effects throughout the study period.
CONDITIONS
Brief 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 must be estrogen receptor-positive (ER+) and HER2-negative (HER2-) as per accepted guidelines.
- Disease progression during or after treatment with a CDK4/6 inhibitor and endocrine therapy.
- Measurable or evaluable disease by RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 6 months.
- Age 18 years or older.
You will not qualify if you...
- Advanced, symptomatic, visceral spread at risk of life-threatening complications requiring cytotoxic chemotherapy.
- More than one prior line of therapy for locally advanced or metastatic disease.
- Prior chemotherapy for metastatic breast cancer.
- Treatment with oral endocrine therapy within 7 days or fulvestrant/CDK4/6 inhibitor within 21 days before starting study drug.
- Malabsorption or gastrointestinal conditions affecting drug absorption.
- History of other malignancies within 3 years, except for those with low risk of metastasis or death.
- Known allergy or hypersensitivity to study treatment components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles until unacceptable toxicity, disease progression, or loss of clinical benefit
Participants receive oral drug treatment with GDC-4198 alone or in combination with giredestrant, or abemaciclib with giredestrant, in 28-day cycles until unacceptable toxicity, disease progression, or loss of clinical benefit.
Visits occur each cycle during treatment
Trial Site Locations
Total: 39 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
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-1503
Actively Recruiting
4
UCSF Helen Diller Family CCC
San Francisco, California, United States, 94158
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322-1013
Actively Recruiting
7
City of Hope® Cancer Center Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
8
Barbara Ann Karmanos Cancer Institute
Detroit, Maine, United States, 48201-2013
Actively Recruiting
9
Washington University Siteman Cancer Center
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
10
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901-1914
Actively Recruiting
11
New York Cancer & Blood Specialists
East Patchogue, New York, United States, 11772
Actively Recruiting
12
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213-3108
Actively Recruiting
14
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204-3609
Actively Recruiting
15
Texas Oncology (Worth) - USOR
Dallas, Texas, United States, 75246-2003
Actively Recruiting
16
Virginia Oncology Associates (Norfolk) - USOR
Norfolk, Virginia, United States, 23502-2800
Actively Recruiting
17
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
18
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
19
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil, 50040-000
Actively Recruiting
20
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Actively Recruiting
21
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
Actively Recruiting
22
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
23
Institut Jean Godinot
Reims, Champagne-Ardenne, France, 51100
Actively Recruiting
24
Gustave Roussy
Villejuif, Val-de-Marne, France, 94805
Actively Recruiting
25
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
26
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
27
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
28
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
29
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardy, Italy, 25123
Actively Recruiting
30
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea, 6273
Actively Recruiting
31
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
32
Asan Medical Center.
Seoul, South Korea, 05505
Actively Recruiting
33
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
34
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
35
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, Spain, 08035
Actively Recruiting
36
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
37
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
38
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
39
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
R
Reference Study ID Number: GO46021 https://forpatients.roche.com/
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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