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

ClinicalTrials.gov ID: NCT07100106

Public ClinicalTrials.gov record NCT07100106. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07100106
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Genentech, Inc.; Industry
Enrollment: 285 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 6, 2025
Primary completion: Aug 30, 2028
Completion: Aug 30, 2028
Last update posted: Aug 9, 2026

2025 – 2028

United States locations

U.S. sites: 26
U.S. states: 17
U.S. cities: 25

Facility	City	State	ZIP	Site status
University of Arizona Cancer Center	Tucson	Arizona	85724-0001	Recruiting
City of Hope	Duarte	California	91010	Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center	Irvine	California	92618	Recruiting
UC San Diego Moores Cancer Center	La Jolla	California	92093-1503	Recruiting
University of California San Diego Medical Center	San Diego	California	92103-1911	Recruiting
UCSF Helen Diller Family CCC	San Francisco	California	94158	Recruiting
Sylvester Comprehensive Cancer Center	Miami	Florida	33136-1002	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Winship Cancer Institute of Emory University	Atlanta	Georgia	30322-1013	Recruiting
City of Hope® Cancer Center Chicago	Zion	Illinois	60099	Recruiting
Barbara Ann Karmanos Cancer Institute	Detroit	Maine	48201-2013	Recruiting
Maryland Oncology Hematology - Annapolis	Annapolis	Maryland	21401	Recruiting
Washington University Siteman Cancer Center	St Louis	Missouri	63110-1010	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	08901-1914	Recruiting
New York Cancer & Blood Specialists	East Patchogue	New York	11772	Recruiting
Montefiore Einstein Cancer Center	The Bronx	New York	10461	Recruiting
Levine Cancer Institute	Charlotte	North Carolina	28204	Recruiting
Novant Health Cancer Institute	Charlotte	North Carolina	28204	Recruiting
Oncology Associates of Oregon, P.C	Eugene	Oregon	97401	Recruiting
Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033-2360	Recruiting
University of Pennsylvania - Abramson Cancer Center	Philadelphia	Pennsylvania	19104	Recruiting
UPMC - Hillman Cancer Center	Pittsburgh	Pennsylvania	15213-3108	Recruiting
Vanderbilt Breast Center at One Hundred Oaks	Nashville	Tennessee	37204-3609	Recruiting
Texas Oncology (Worth) - USOR	Dallas	Texas	75246-2003	Recruiting
University of Utah Huntsman Cancer Institute	Salt Lake City	Utah	84013	Recruiting
Virginia Oncology Associates (Norfolk) - USOR	Norfolk	Virginia	23502-2800	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07100106, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 9, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07100106 live on ClinicalTrials.gov.

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