Clinical trial • Phase II | Phase IV • Oncology

Patritumab deruxtecan (U3-1402) for Advanced breast cancer | Hormone receptor-positive (HR+) HER2-negative advanced breast cancer

Phase II | Phase IV trial of Patritumab deruxtecan (U3-1402) for Advanced breast cancer | Hormone receptor-positive (HR+) HER2-negative advanced breast ca…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced breast cancer | Hormone receptor-positive (HR+) HER2-negative advanced breast cancer
Trial Stage
Phase II | Phase IV
Drug Modality
ADC | Monoclonal antibody

Key dates

Initial CTIS Submission Date
07-08-2024
First CTIS Authorization Date
21-08-2024

Trial design

open-label Phase II | Phase IV trial across 11 sites in France.

Open Label
Yes
Target Sample Size
139

Eligibility

Recruits 139 Vulnerable population selected (isVulnerablePopulationSelected = true); population described as adults. No specific information provided on consent or assent procedures in the available data..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true); population described as adults. No specific information provided on consent or assent procedures in the available data.

Recruitment

Planned Sample Size
139
Recruitment Window Months
116
Consent Approach
Not specified in the provided data; no details on informed consent/assent processes, who provides consent, age-specific documents, or languages available.

Geography

Total Number Of Sites
11
Total Number Of Participants
139

France

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
464
Number Of Sites
11
Number Of Participants
139

Sites

Site Name
Institut de Cancérologie de l'Ouest - site de Saint Herblain
Department Name
ONCOLOGIE
Contact Person Name
Jean-sebastien FRENEL
Site Name
Centre Antoine Lacassagne
Department Name
ONCOLOGIE
Contact Person Name
Agnes DUCOULOMBIER
Site Name
Institut Gustave Roussy
Department Name
ONCOLOGIE
Contact Person Name
Barbara PISTILLI
Site Name
Institut Curie
Department Name
ONCOLOGIE
Contact Person Name
Delephine LOIRAT
Contact Person Email
delphine.loirat@curie.fr
Site Name
Institut Claudius Regaud / Oncopole / CHU Toulouse
Department Name
ONCOLOGIE
Contact Person Name
Florence DALENC
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
ONCOLOGIE
Contact Person Name
Véronique D'HONDT
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
ONCOLOGIE
Contact Person Name
Elise DELUCHE
Contact Person Email
Elise.DELUCHE@chu-limoges.fr
Site Name
Centr Georges Francois Leclerc
Department Name
ONCOLOGIE
Contact Person Name
Didier MAYEUR
Contact Person Email
dmayeur@cgfl.fr
Site Name
Centre Leon Berard
Department Name
ONCOLOGIE
Contact Person Name
Thomas BACHELOT
Site Name
Institut Paoli Calmettes
Department Name
ONCOLOGIE
Contact Person Name
Cecile VICIER
Contact Person Email
VICIERC@ipc.unicancer.fr
Site Name
Hopital Tenon
Department Name
ONCOLOGIE
Contact Person Name
Xavier BARTHERE
Contact Person Email
XAVIER.BARTHERE@APHP.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
Patritumab Deruxtecan (U3-1402)
Active Substance
Patritumab deruxtecan (U3-1402)
Modality
ADC

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