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

Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07100106
Protocol IDs
GO46021 (primary)
NCI-2025-06239
2025-521128-31-00
Study Sponsor
Genentech Inc.

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.

Eligibility

  1. Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.
  2. 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.
  3. Disease progression during or after treatment with an approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting.
  4. Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. Life expectancy >= 6 months.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.