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
Recruiting · NCT07100106 · Interventional (participants receive a specific treatment) · Lead sponsor: Genentech, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 18 US 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
- 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
- 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
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON - Barcelona, Spain
- Centre Francois Baclesse - Caen, France
- Universitatsklinikum Hamburg-Eppendorf - Hamburg, Germany
- Centre Oscar Lambret - Lille, France
- Hospital Beata Maria Ana - Madrid, Spain
- Hospital General Universitario Gregorio Maranon - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Guangxi Cancer Hospital of Guangxi Medical University - Nanning, China
- Centre Eugene Marquis - Rennes, France
- 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 Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP - São Paulo, Brazil
- Hospital Clinico Universitario de Valencia - Valencia, Spain
- Universitatsklinikum Tubingen - Tübingen, Baden-Wurttemberg, Germany
- Institut Jean Godinot - Reims, Champagne-Ardenne, France
- 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 degli Spedali Civili di Brescia - Spedali Civili di Brescia - Brescia, Lombardy, Italy
- Ospedale San Raffaele S.r.l. - PPDS - Milan, Lombardy, Italy
- St Vincent's Hospital Sydney - Darlinghurst, New South Wales, Australia
- KEM - Evang. Huyssens-Stiftung Essen-Huttrop - Essen, North Rhine-Westphalia, Germany
- Princess Margaret Hospital - Toronto, Ontario, Canada
- 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
- Shandong Cancer Hospital - Jinan, SD, China
- Gangnam Severance Hospital, Yonsei University Health System - Seoul, Seoul Teugbyeolsi, South Korea
Showing 60 of 64 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →