Clinical trial • Phase III • Oncology
GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
Phase III trial of GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer. 113 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Locally advanced or metastatic estrogen receptor-positive breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule | Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 21-02-2024
- First CTIS Authorization Date
- 23-02-2024
Trial design
Phase III trial across 7 sites in Spain.
- Target Sample Size
- 113
Eligibility
Recruits 113 Vulnerable population selected (isVulnerablePopulationSelected=true). No details on consent or assent handling are available in the provided record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). No details on consent or assent handling are available in the provided record.
Recruitment
- Planned Sample Size
- 113
- Recruitment Window Months
- 83
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 113
Spain
- Earliest CTIS Part Ii Submission Date
- 26-06-2023
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 651
- Number Of Sites
- 7
- Number Of Participants
- 45
Sites
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncologia
- Contact Person Name
- Laura Garcia Estevez
- Contact Person Email
- lgestevez@mdanderson.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncologia Medica
- Contact Person Name
- Emiliano Calvo
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncologia Medica
- Contact Person Name
- Elena Lopez Miranda
- Contact Person Email
- mbellet@vhio.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncologia Medica
- Contact Person Name
- Sara Lopez-Tarruella Cobo
- Contact Person Email
- slopeztarruella@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncologia Medica
- Contact Person Name
- Jose Alejandro Perez-Fidalgo
- Contact Person Email
- japfidalgo@msn.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncologia Medica
- Contact Person Name
- Rafael Villanueva Vazquez
- Contact Person Email
- ravillanueva@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia Medica
- Contact Person Name
- Meritxell Bellet Ezquerra
- Contact Person Email
- mbellet@vhio.net
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- GDC-9545
- Modality
- Small molecule
- Investigational Product Name
- Palbociclib
- Modality
- Small molecule
- Investigational Product Name
- LHRH agonist
- Modality
- Peptide/protein/enzyme
- Combination Treatment
- Yes
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