A Prospective Non-interventional Study (NIS) of Trastuzumab DeRuxtecan (T-DXd) for Adult Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction (GEJ) AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen, Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies in a Real-world Setting in Europe (PROSPERITY)
Status: Recruiting
Location: See all (76) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. This study will assess the effectiveness of T-DXd, patient demographic and clinical characteristics, and treatment patterns in patients with advanced HER2-positive advanced gastric or GEJ adenocarcinoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female adult patient (age ≥ 18 years) with HER2 + advanced gastric or GEJ adenocarcinoma who have received a prior trastuzumab based regimen
• Histological or cytological confirmed diagnosis of advanced HER2 positive gastric cancer or GEJ
• Documented HER2 + status (archival sample or recent sample prior 2L therapy)
• Decision to newly initiate monotherapy T-DXd or conventional therapies per SMPC according to the physician's choice
• Written dated and signed Informed Consent (ICF) to participate in the study
Locations
Other Locations
Austria
KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH
ACTIVE_NOT_RECRUITING
Klagenfurt
Ordensklinikum Linz GmbH Barmherzige Schwestern
ACTIVE_NOT_RECRUITING
Linz
Universitätsklinikum St. Pölten - Lilienfeld
ACTIVE_NOT_RECRUITING
Sankt Pölten
Klinik Ottakring, Wilhelminenspital der Stadt Wien
ACTIVE_NOT_RECRUITING
Vienna
Medizinische Universität Wien
ACTIVE_NOT_RECRUITING
Vienna
St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe
WITHDRAWN
Vienna
Kepler Universitätsklinikum
ACTIVE_NOT_RECRUITING
Wels
Landesklinikum Wiener Neustadt
ACTIVE_NOT_RECRUITING
Wiener Neustadt
Krankenhaus St. Vinzenz in Zams
ACTIVE_NOT_RECRUITING
Zams
Belgium
OLV Hospital Aalst
RECRUITING
Aalst
Imelda vzw
RECRUITING
Bonheiden
HUB institut Jules Bordet
RECRUITING
Brussels
Grand hôpital de Charleroi
RECRUITING
Charleroi
Antwerp University Hospital
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
CHU Helora Hospital de La Louvière - Site Jolimont
RECRUITING
Haine-saint-paul
JESSA Hasselt
RECRUITING
Hasselt
UZ Brussel
RECRUITING
Jette
UZ Leuven
RECRUITING
Leuven
AZ Delta
WITHDRAWN
Roeselare
Germany
MVZ am Klinikum Aschaffenburg
ACTIVE_NOT_RECRUITING
Aschaffenburg
Universitätsklinikum Augsburg
WITHDRAWN
Augsburg
Charite Campus Benjamin Franklin
ACTIVE_NOT_RECRUITING
Berlin
Vivantes Klinikum im Friedrichshain
ACTIVE_NOT_RECRUITING
Berlin
Klinikum Chemnitz gGmbH
ACTIVE_NOT_RECRUITING
Chemnitz
MV-Zentrum für Hämatologie & Onkologie
ACTIVE_NOT_RECRUITING
Cologne
Universitätsklinikum Düsseldorf
ACTIVE_NOT_RECRUITING
Düsseldorf
University Hospital Essen
ACTIVE_NOT_RECRUITING
Essen
Universitaetsklinikum Giessen und Marburg, Standort Giessen
ACTIVE_NOT_RECRUITING
Giessen
Alb Fils Kliniken GmbH
ACTIVE_NOT_RECRUITING
Göppingen
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
ACTIVE_NOT_RECRUITING
Hamburg
Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
ACTIVE_NOT_RECRUITING
Hanover
KRH Klinikum Siloah
ACTIVE_NOT_RECRUITING
Hanover
Studienzentrum am Raschplatz GbR
ACTIVE_NOT_RECRUITING
Hanover
Städtisches Klinikum Karlsruhe
ACTIVE_NOT_RECRUITING
Karlsruhe
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH
ACTIVE_NOT_RECRUITING
Leipzig
Praxis Hämatologie und Onkologie Magdeburg
WITHDRAWN
Magdeburg
Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
ACTIVE_NOT_RECRUITING
Magdeburg
Klinikum rechts der Isar der Technischen Universität München
ACTIVE_NOT_RECRUITING
München
Pi.Tri-Studien GmbH
WITHDRAWN
Offenburg
Klinikum am Steinenberg Reutlingen
ACTIVE_NOT_RECRUITING
Reutlingen
Nädler GmbH
ACTIVE_NOT_RECRUITING
Rinteln
CaritasKlinikum Saarbrücken
ACTIVE_NOT_RECRUITING
Saarbrücken
Praxis Onkologie Rheinsieg
ACTIVE_NOT_RECRUITING
Troisdorf
Universitätsklinikum Würzburg (UKW)
WITHDRAWN
Würzburg
Italy
AOU delle Marche
RECRUITING
Ancona Torrette
ASL AT - Presidio Ospedaliero Cardinal Massaia
RECRUITING
Asti
IRCCS S. De Bellis
RECRUITING
Castellana Grotte
ARNAS Garibaldi - PO Nesima
RECRUITING
Catania
AOU Careggi
RECRUITING
Florence
IRCCS AOU San Martino
RECRUITING
Genova
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena
RECRUITING
Modena
A.O.U. Cagliari - Policlinico Universitario Duilio Casula
RECRUITING
Monserrato
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING
Naples
Università degli studi di Napoli Federico II
RECRUITING
Naples
Università della Campania 'Luigi Vanvitelli'
RECRUITING
Naples
AOU Pisana - Stabilimento Santa Chiara
RECRUITING
Pisa
Azienda Sanitaria Locale di Biella - Ospedale degli Infermi
RECRUITING
Ponderano
AUSL della Romagna - Ospedale S. Maria delle Croci di Ravenna
RECRUITING
Ravenna
AO San Camillo Forlanini
RECRUITING
Roma
AO San Giovanni Addolorata
RECRUITING
Roma
Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
AO Cardinale Giovanni Panico
RECRUITING
Tricase
ASU FC - Ospedale Santa Maria della Misericordia
RECRUITING
Udine
Azienda ULSS 8 Berica - Ospedale San Bortolo
RECRUITING
Vicenza
Portugal
ULS Almada-Seixal
NOT_YET_RECRUITING
Almada
USL Braga
NOT_YET_RECRUITING
Braga
ULS Coimbra
NOT_YET_RECRUITING
Coimbra
CC Champalimaud
NOT_YET_RECRUITING
Lisbon
Hospital da Luz
NOT_YET_RECRUITING
Lisbon
IPO Lisboa
NOT_YET_RECRUITING
Lisbon
ULS Santo António
NOT_YET_RECRUITING
Porto
Vila Real
RECRUITING
Vila Real
Contact Information
Primary
Contact for Clinical Trial Information
CTRinfo@dsi.com
908-992-6400
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 257
Treatments
Trastuzumab deruxtecan (T-DXd)
Participants with HER2-positive gastric or gastroesophageal junction adenocarcinoma who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional therapy. The participants on conventional therapy will be analyzed for exploratory purposes only.
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company