Clinical trial • Phase III • Oncology
Clinical trial in Breast cancer
Phase III trial for Breast cancer. 106 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 19-08-2024
- First CTIS Authorization Date
- 05-11-2024
Trial design
Phase III trial across 22 sites in Belgium, France, Portugal and others.
- Target Sample Size
- 106
Eligibility
Recruits 106 No vulnerable populations selected; isVulnerablePopulationSelected is false in the record and no consent/assent handling information is provided..
- Vulnerable Population
- No vulnerable populations selected; isVulnerablePopulationSelected is false in the record and no consent/assent handling information is provided.
Recruitment
- Planned Sample Size
- 106
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 98
Belgium
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 26-11-2024
- Processing Time Days
- 11
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Medical Oncology Department
- Contact Person Name
- Jean-Paul Salmon
- Contact Person Email
- jean.paul.salmon@citadelle.be
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology Department
- Contact Person Name
- Konstantinos Papadimitriou
- Contact Person Email
- konstantinos.papadimitriou@uza.be
- Site Name
- UZ Leuven
- Department Name
- Gynaecological Oncology Department
- Contact Person Name
- Patrick Neven
- Contact Person Email
- patrick.neven@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 05-11-2024
- Processing Time Days
- 64
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Foch
- Department Name
- Medical Oncology Department
- Contact Person Name
- Asmahane Benmaziane-Teillet
- Contact Person Email
- a.benmaziane@hopital-foch.com
- Site Name
- Polyclinique Bordeaux Nord Aquitaine
- Department Name
- Medical Oncology Department
- Contact Person Name
- Dohollou Nadine
- Contact Person Email
- n.dohollou@bordeauxnord.com
- Site Name
- Centre Francois Baclesse
- Department Name
- Medical Oncology Department
- Contact Person Name
- George Emile
- Contact Person Email
- g.emile@baclesse.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Medical Oncology Department
- Contact Person Name
- Nicolas Isambert
- Contact Person Email
- Nicolas.ISAMBERT@chu-poitiers.fr
Portugal
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 07-11-2024
- Processing Time Days
- 66
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Unidade Local De Saude De Amadora Sintra E.P.E.
- Department Name
- Oncology
- Contact Person Name
- Marta Batista
- Contact Person Email
- marta.vaz@hff.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Oncology
- Contact Person Name
- Catarina Portela
- Contact Person Email
- 2ca@ccabraga.org
Spain
- Earliest CTIS Part Ii Submission Date
- 14-11-2024
- Latest Decision Or Authorization Date
- 10-12-2024
- Processing Time Days
- 26
- Number Of Sites
- 11
- Number Of Participants
- 56
Sites
- Site Name
- MD Anderson Cancer Center
- Department Name
- Medical Oncology
- Contact Person Name
- Maria Isabel Calvo Plaza
- Contact Person Email
- micalvop@mdanderson.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Ophthalmology
- Contact Person Name
- Maria Sanchidrian Mayo
- Contact Person Email
- msanchidrianma@saludcastillayleon.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Contact Person Name
- Francesco Schettini
- Contact Person Email
- schettini@clinic.cat
- Site Name
- Hospital Universitario Severo Ochoa
- Department Name
- Medical Oncology
- Contact Person Name
- Maria Jose Echarri Gonzalez
- Contact Person Email
- mecharrigonzalez@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Ophthalmology
- Contact Person Name
- Nelida Muñoz Sanz
- Contact Person Email
- nmunozsa@fjd.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Contact Person Name
- Raquel Bratos Lorenzo
- Contact Person Email
- rbratos@hmhospitales.com
- Site Name
- Hospital Del Mar
- Department Name
- Medical Oncology
- Contact Person Name
- Tamara Martos Cardenas
- Contact Person Email
- tmartoscardenas@psmar.cat
- Site Name
- Hospital Beata Maria Ana
- Department Name
- Medical Oncology
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- javier.cortes@maj3.health
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Medical Oncology
- Contact Person Name
- Blanca Cantos Sanchez de Ibarguen
- Contact Person Email
- blanca.cantos@salud.madrid.org
- Site Name
- Consorci Sanitari Integral
- Department Name
- Medical Oncology
- Contact Person Name
- Sabela Recalde
- Contact Person Email
- srecalde@iconcologia.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Contact Person Name
- Yolanda Jerez Gilarranz
- Contact Person Email
- yolanda.jerez@salud.madrid.org
Poland
- Earliest CTIS Part Ii Submission Date
- 10-06-2025
- Latest Decision Or Authorization Date
- 14-07-2025
- Processing Time Days
- 34
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Instytut Msf Sp. z o.o.
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- ewakalinka@wp.pl
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddział Dzienny Chemioterapii
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- mariusz.kwiatkowski@swk.med.pl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
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