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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT07100106
Trial Phases:	Phase I Phase II	Protocol IDs:	GO46021 (primary) NCI-2025-06239 2025-521128-31-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Genentech Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT07100106

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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