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Clinical Trials in the USA / NCT07100106
Recruiting Phase 1/2

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 · tracked via the Priya Life Science USA tracker
Sponsor
Genentech, Inc.
Phase
Phase 1/2
Started
2025-10-07
Last updated
2026-09-08

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

GDC-4198GiredestrantAbemaciclib

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic. * 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. * 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. * Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Life expectancy \>= 6 months. Exclusion Criteria: * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines. * Have received more than one-line of therapy for locally advanced or metastatic disease. * Have received prior chemotherapy for metastatic breast cancer. * Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4/6 inhibitor within 21 days prior to initiation of study drug. * Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption * History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death. * Known allergy or hypersensitivity to any component of the study treatments.

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA