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(s) studied
Investigational drug(s) / intervention(s)
GDC-4198: GDC-4198 will be administered orally.
Giredestrant: Giredestrant will be administered orally.
Abemaciclib: Abemaciclib will be administered orally.
Study 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
Primary outcome measure(s)
- Phase Ib: Incidence and Severity of Adverse Events (AEs) — Up to 36 months
Severity of AEs determined according to the CTCAE v5.0 grading scale - Phase Ib: Number of Participants With Dose-Limiting Toxicity (DLTs) — From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
- Phase II: Progression-free Survival (PFS) — Up to 36 months
Trial sites (64)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| City of Hope | Duarte | California | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center | Irvine | California | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| University of California San Diego Medical Center | San Diego | California | Recruiting |
| UCSF Helen Diller Family CCC | San Francisco | California | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | Recruiting |
| City of Hope® Cancer Center Chicago | Zion | Illinois | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Maine | Recruiting |
| Maryland Oncology Hematology - Annapolis | Annapolis | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Washington University Siteman Cancer Center | St Louis | Missouri | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Recruiting |
| New York Cancer & Blood Specialists | East Patchogue | New York | Recruiting |
| Montefiore Einstein Cancer Center | The Bronx | New York | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | Recruiting |
| Novant Health Cancer Institute | Charlotte | North Carolina | Recruiting |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | Recruiting |
| Oncology Associates of Oregon, P.C | Eugene | Oregon | Recruiting |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | Recruiting |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| UPMC - Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | Recruiting |
| Texas Oncology (Worth) - USOR | Dallas | Texas | Recruiting |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | Recruiting |
| Virginia Oncology Associates (Norfolk) - USOR | Norfolk | Virginia | Recruiting |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | Recruiting |
| Cancer Research SA | Adelaide | South Australia | Recruiting |
| Hospital do Cancer de Pernambuco - HCP | Recife | Pernambuco | Recruiting |
| ONCOSITE Centro de Pesquisa Clínica Em Oncologia | Ijuí | Rio Grande do Sul | Recruiting |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital de Clinicas de Porto Alegre (HCPA) - PPDS | Porto Alegre | Rio Grande do Sul | Recruiting |
| Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP | São Paulo | Brazil | Recruiting |
| Princess Margaret Hospital | Toronto | Ontario | Recruiting |
| Shandong Cancer Hospital | Jinan | SD | Recruiting |
| Fudan University Shanghai Cancer Center - Pudong Campus | Shanghai | Shanghai Municipality | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | Recruiting |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | China | Recruiting |
+ 24 more sites — see the full list on the official registry below.
On this site
📄 Verzenio (abemaciclib) drug profile →More Genentech, Inc. trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07100106 on ClinicalTrials.gov ↗ ← All trials in Italy