Clinical trial • Phase I/II • Oncology
Clinical trial in Triple-negative breast cancer | Early relapsed metastatic breast cancer
Phase I/II trial for Triple-negative breast cancer | Early relapsed metastatic breast cancer. open-label, none/not specified-controlled, adaptive.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Triple-negative breast cancer | Early relapsed metastatic breast cancer
- Trial Stage
- Phase I/II
Key dates
- Initial CTIS Submission Date
- 15-09-2023
- First CTIS Authorization Date
- 15-01-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 5 sites in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True - dose-finding (dose-escalation) and dose-expansion modular design; no specific escalation rules or interim analysis details provided in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 50
Eligibility
Recruits 50 isVulnerablePopulationSelected is true; no details on consent or assent handling provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected is true; no details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 52
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 50
France
- Earliest CTIS Part Ii Submission Date
- 04-12-2023
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 872
- Number Of Sites
- 5
- Number Of Participants
- 50
Sites
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Oncology
- Contact Person Name
- Perrine VUAGNAT
- Contact Person Email
- p.vuagnat@rennes.unicancer
- Site Name
- Institut Paoli Calmettes
- Department Name
- oncology
- Contact Person Name
- ARTHUR GERAUD
- Contact Person Email
- Geraudcremieuxa@ipc.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Breast Cancer Unit
- Contact Person Name
- THOMAS GRINDA
- Contact Person Email
- Thomas.grinda@gustaveroussy.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- oncology
- Contact Person Name
- Florence DALENC
- Contact Person Email
- Dalenc.florence@iuct-oncopole.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- oncology
- Contact Person Name
- Véronique D'HONDT
- Contact Person Email
- Veronique.Dhondt@icm.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Institut Gustave Roussy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
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