Clinical trial • Phase IV • Oncology
Durvalumab for Triple-negative breast cancer | Untreated small triple-negative breast cancer
Phase IV trial of Durvalumab for Triple-negative breast cancer | Untreated small triple-negative breast cancer. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Triple-negative breast cancer | Untreated small triple-negative breast cancer
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 12-04-2024
- First CTIS Authorization Date
- 26-04-2024
Trial design
None/Not specified-controlled Phase IV trial in France.
- Comparator
- None/Not specified
- Target Sample Size
- 100
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 55
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 100
France
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 26-04-2024
- Processing Time Days
- 45
- Number Of Sites
- 4
- Number Of Participants
- 100
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- ONCOLOGIE
- Principal Investigator Name
- Joana Trindade Mourato Lopes RIBEIRO
- Principal Investigator Email
- joana-mourato.ribeiro@gustaveroussy.fr
- Contact Person Name
- Joana Trindade Mourato Lopes RIBEIRO
- Contact Person Email
- joana-mourato.ribeiro@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- ONCOLOGIE
- Principal Investigator Name
- Olivier TREDAN
- Principal Investigator Email
- olivier.tredan@lyon.unicancer.fr
- Contact Person Name
- Olivier TREDAN
- Contact Person Email
- olivier.tredan@lyon.unicancer.fr
- Site Name
- Centre Jean Perrin
- Department Name
- ONCOLOGIE
- Principal Investigator Name
- MOURET-REYNIER Marie-Ange
- Principal Investigator Email
- marie-ange.mouret-reynier@clermont.unicancer.fr
- Contact Person Name
- MOURET-REYNIER Marie-Ange
- Contact Person Email
- marie-ange.mouret-reynier@clermont.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- ONCOLOGIE
- Principal Investigator Name
- Herve BONNEFOIS
- Principal Investigator Email
- h.bonnefoi@bordeaux.unicancer.fr
- Contact Person Name
- Herve BONNEFOIS
- Contact Person Email
- h.bonnefoi@bordeaux.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Institut Gustave Roussy
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Durvalumab (MEDI 4736)
- Active Substance
- Durvalumab
- Modality
- Monoclonal antibody
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