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
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

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
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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