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
NCT ID: NCT07100106
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
285 participants
INTERVENTIONAL
2025-10-07
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase Ib: Dose-Finding Stage
Participants will receive GDC-4198 as monotherapy and in combination with giredestrant, 30 milligrams (mg), orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
GDC-4198
GDC-4198 will be administered orally.
Giredestrant
Giredestrant will be administered orally.
Phase II: Arm A
Participants will receive GDC-4198, higher dose, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
GDC-4198
GDC-4198 will be administered orally.
Giredestrant
Giredestrant will be administered orally.
Phase II: Arm B
Participants will receive GDC-4198, lower dose, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
GDC-4198
GDC-4198 will be administered orally.
Giredestrant
Giredestrant will be administered orally.
Phase II: Arm C
Participants will receive abemaciclib, 150 mg twice daily, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days).
Giredestrant
Giredestrant will be administered orally.
Abemaciclib
Abemaciclib will be administered orally.
Interventions
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GDC-4198
GDC-4198 will be administered orally.
Giredestrant
Giredestrant will be administered orally.
Abemaciclib
Abemaciclib will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines.
* Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine therapy (ET) in the locally advanced or metastatic setting.
* Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy ≥ 6 months
Exclusion Criteria
* Have received more than one-line of therapy for locally advanced or metastatic disease.
* Have received prior chemotherapy for metastatic breast cancer
* Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half -lives, whichever is shorter, prior to initiation of study drug. Treatment with an approved oral endocrine therapy (ET) within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4/6 inhibitor within 21 days prior to initiation of study drug.
* Poor peripheral venous access
* Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption
* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.
18 Years
ALL
No
Sponsors
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Roche (China) Holding Ltd.
UNKNOWN
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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City of Hope
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, 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
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York Cancer & Blood Specialists
East Patchogue, New York, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Princess Margaret Hospital
Toronto, Ontario, Canada
Institut Jean Godinot
Reims, Champagne-Ardenne, France
Hospital Beata Maria Ana
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Reference Study ID Number: GO46021 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2025-521128-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
GO46021
Identifier Type: -
Identifier Source: org_study_id
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