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 (NCT07100106)
A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona Cancer Center — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (61 Sites)
Showing the first 25 of 61 sites.
- University of Arizona Cancer Center — Tucson, Arizona
- City of Hope — Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center — Irvine, California
- UC San Diego Moores Cancer Center — La Jolla, California
- University of California San Diego Medical Center — San Diego, California
- UCSF Helen Diller Family CCC — San Francisco, California
- Sylvester Comprehensive Cancer Center — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- City of Hope® Cancer Center Chicago — Zion, Illinois
- Barbara Ann Karmanos Cancer Institute — Detroit, Maine
- Maryland Oncology Hematology - Annapolis — Annapolis, Maryland
- Washington University Siteman Cancer Center — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- New York Cancer & Blood Specialists — East Patchogue, New York
- Montefiore Einstein Cancer Center — The Bronx, New York
- Levine Cancer Institute — Charlotte, North Carolina
- Novant Health Cancer Institute — Charlotte, North Carolina
- Oncology Associates of Oregon, P.C — Eugene, Oregon
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania
- University of Pennsylvania - Abramson Cancer Center — Philadelphia, Pennsylvania
- UPMC - Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee
- Texas Oncology (Worth) - USOR — Dallas, Texas
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.