RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Genentech, Inc. • ClinicalTrials.gov ID: NCT07100106

Registry updated: 2026-10-06

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

GDC-4198 (Drug)
GDC-4198 will be administered orally.
Giredestrant (Drug)
Giredestrant will be administered orally.
Abemaciclib (Drug)
Abemaciclib will be administered orally.

Eligibility criteria

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.

Conditions

Breast Cancer

Locations

Clearview Cancer Institute - Huntsville — Huntsville, Alabama, United States
University of Arizona Cancer Center — Tucson, Arizona, United States
City of Hope — Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center — Irvine, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
University of California San Diego Medical Center — San Diego, California, United States
UCSF Helen Diller Family CCC — San Francisco, California, United States
University of Colorado Cancer Center — Aurora, Colorado, United States
Sylvester Comprehensive Cancer Center — Miami, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
City of Hope® Cancer Center Chicago — Zion, Illinois, United States
Barbara Ann Karmanos Cancer Institute — Detroit, Maine, United States
Maryland Oncology Hematology - Annapolis — Annapolis, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Washington University Siteman Cancer Center — St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
New York Cancer & Blood Specialists — East Patchogue, New York, United States
Montefiore Einstein Cancer Center — The Bronx, New York, United States
Levine Cancer Institute — Charlotte, North Carolina, United States
Novant Health Cancer Institute — Charlotte, North Carolina, United States
Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States
Cleveland Clinic Mercy Hospital — Canton, Ohio, United States
Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
Oncology Associates of Oregon, P.C — Eugene, Oregon, United States
Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
University of Pennsylvania - Abramson Cancer Center — Philadelphia, Pennsylvania, United States
UPMC - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee, United States
Texas Oncology (Worth) - USOR — Dallas, Texas, United States
University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
Virginia Oncology Associates (Norfolk) - USOR — Norfolk, Virginia, United States
St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
Cancer Research SA — Adelaide, South Australia, Australia
Hospital do Cancer de Pernambuco - HCP — Recife, Pernambuco, Brazil
ONCOSITE Centro de Pesquisa Clínica Em Oncologia — Ijuí, Rio Grande do Sul, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS — Porto Alegre, Rio Grande do Sul, Brazil
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP — São Paulo, Brazil
Beneficencia Portuguesa de Sao Paulo — São Paulo, Brazil
Princess Margaret Hospital — Toronto, Ontario, Canada
Shandong Cancer Hospital — Jinan, SD, China
Fudan University Shanghai Cancer Center - Pudong Campus — Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China
Fujian Cancer Hospital — Fuzhou, China
Guangxi Cancer Hospital of Guangxi Medical University — Nanning, China
Institut Jean Godinot — Reims, Champagne-Ardenne, France
Gustave Roussy — Villejuif, Val-de-Marne, France
Centre Francois Baclesse — Caen, France
Centre Oscar Lambret — Lille, France
Centre Eugene Marquis — Rennes, France
Universitatsklinikum Tubingen — Tübingen, Baden-Wurttemberg, Germany
Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany
KEM - Evang. Huyssens-Stiftung Essen-Huttrop — Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany
Universitatsklinikum Hamburg-Eppendorf — Hamburg, Germany
Uniklinikum Heidelberg — Heidelberg, Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna — Bologna, Emilia-Romagna, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS — Meldola, Emilia-Romagna, Italy
Asst Papa Giovanni XXIII — Bergamo, Lombardy, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia — Brescia, Lombardy, Italy
Ospedale San Raffaele S.r.l. - PPDS — Milan, Lombardy, Italy
Gangnam Severance Hospital, Yonsei University Health System — Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Bundang Hospital — Seongnam-si, South Korea
Seoul National University Hospital — Seoul, South Korea
Asan Medical Center. — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Severance Hospital, Yonsei University Health System — Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain
Hospital Beata Maria Ana — Madrid, Spain
Hospital General Universitario Gregorio Maranon — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Clinico Universitario de Valencia — Valencia, Spain

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment