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Study identifier: NCT07100106 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: Breast Cancer  ·  Sponsor: Genentech, Inc.

PhasePhase 1/Phase 2
Planned participants285
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: GO46021 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (52)

City of HopeDuarte, California, United StatesRecruiting
City of Hope - Orange County Lennar Foundation Cancer CenterIrvine, California, United StatesRecruiting
UC San Diego Moores Cancer CenterLa Jolla, California, United StatesRecruiting
UCSF Helen Diller Family CCCSan Francisco, California, United StatesRecruiting
Sylvester Comprehensive Cancer CenterMiami, Florida, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Winship Cancer Institute of Emory UniversityAtlanta, Georgia, United StatesRecruiting
City of Hope® Cancer Center ChicagoZion, Illinois, United StatesRecruiting
Barbara Ann Karmanos Cancer InstituteDetroit, Maine, United StatesRecruiting
Washington University Siteman Cancer CenterSt Louis, Missouri, United StatesRecruiting
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesRecruiting
New York Cancer & Blood SpecialistsEast Patchogue, New York, United StatesRecruiting

+ 40 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07100106