Trial Title:
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)
NCT ID:
NCT05993234
Condition:
HER2-positive Advanced Gastric Cancer
HER2-positive Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Trastuzumab
Trastuzumab deruxtecan
Conditions: Keywords:
HER2-positive Advanced Gastric Cancer
HER2-positive Gastroesophageal Junction Adenocarcinoma
Trastuzumab Deruxtecan
Conventional therapy
ENHERTU®
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab deruxtecan
Description:
This is a non-interventional study and medication will be administered according to the
SmPC as local standard of care and as part of the routine clinical practice.
T-DXd to be administered according to the SmPC. Conventional therapy (eg.
platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel,
ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) to be
administered according to the SmPC.
Arm group label:
Trastuzumab deruxtecan (T-DXd)
Other name:
T-DXd
Other name:
ENHERTU®
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.
Detailed description:
This non-interventional study will investigate the effectiveness of T-DXd, the patients
demographic and clinical characteristics, treatment patterns including prophylactic
medications and interventions for reduction of serious adverse events (SAEs), serious
adverse drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and
patient survey of T-DXd, in cases with advanced HER2-positive gastric or GEJ
adenocarcinoma receiving T-DXd as second line of treatment and beyond treatment option.
Patients will be treated according to the proposed indication statement in the Summary of
Product Characteristics (SmPC). No investigational drug will be administered in this
study.
Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy,
nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and
pembrolizumab monotherapy) will also be collected in a disease registry part of the
study.
Criteria for eligibility:
Study pop:
Adult patients with advanced HER2-positive gastric or GEJ adenocarcinoma who have
received a prior trastuzumab-based regimen in a real-world setting in Europe.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who at time of data collection for this study are participating in or have
participated in an interventional study that remains blinded
- Pregnancy or breastfeeding
No specific exclusion criteria are defined, as patients will be treated according to the
proposed indication statements in the SmPC.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH
Address:
City:
Klagenfurt am Wörthersee
Zip:
9020
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ordensklinikum Linz GmbH Barmherzige Schwestern
Address:
City:
Linz
Zip:
4010
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitätsklinikum St. Pölten - Lilienfeld
Address:
City:
St. Pölten
Zip:
3100
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kepler Universitätsklinikum
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Landesklinikum Wiener Neustadt
Address:
City:
Wiener Neustadt
Zip:
2700
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Medizinische Universität Wien
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe
Address:
City:
Wien
Zip:
1130
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Klinik Ottakring, Wilhelminenspital der Stadt Wien
Address:
City:
Wien
Zip:
1160
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Krankenhaus St. Vinzenz in Zams
Address:
City:
Zams
Zip:
6511
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
OLV Hospital Aalst
Address:
City:
Aalst
Zip:
9300
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
HUB institut Jules Bordet
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Grand hôpital de Charleroi
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
CHU Helora Hospital de La Louvière - Site Jolimont
Address:
City:
Haine-Saint-Paul
Zip:
7100
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
JESSA Hasselt
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
AZ Delta
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
MVZ am Klinikum Aschaffenburg
Address:
City:
Aschaffenburg
Zip:
63739
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitätsklinikum Augsburg
Address:
City:
Augsburg
Zip:
86156
Country:
Germany
Status:
Terminated
Facility:
Name:
Vivantes Klinikum im Friedrichshain
Address:
City:
Berlin
Zip:
10249
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Charite Campus Benjamin Franklin
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Klinikum Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitätsklinikum Düsseldorf
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
University Hospital Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Giessen und Marburg, Standort Giessen
Address:
City:
Gießen
Zip:
35392
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Alb Fils Kliniken GmbH
Address:
City:
Göppingen
Zip:
73035
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
Address:
City:
Hamburg
Zip:
20249
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Studienzentrum am Raschplatz GbR
Address:
City:
Hannover
Zip:
30161
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Städtisches Klinikum Karlsruhe
Address:
City:
Karlsruhe
Zip:
76133
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Praxis Hämatologie und Onkologie Magdeburg
Address:
City:
Magdeburg
Zip:
39104
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
Address:
City:
Magdeburg
Zip:
39120
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Klinikum rechts der Isar der Technischen Universität München
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Pi.Tri-Studien GmbH
Address:
City:
Offenburg
Zip:
77654
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Klinikum am Steinenberg Reutlingen
Address:
City:
Reutlingen
Zip:
72764
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
CaritasKlinikum Saarbrücken
Address:
City:
Saarbrücken
Zip:
66113
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitätsklinikum Würzburg (UKW)
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
AOU delle Marche
Address:
City:
Ancona Torrette
Zip:
60126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
IRCCS "S. De Bellis"
Address:
City:
Castellana Grotte
Zip:
70013
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
ARNAS Garibaldi - PO Nesima
Address:
City:
Catania
Zip:
95122
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
IRCCS AOU San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria di Modena
Address:
City:
Modena
Zip:
41124
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
A.O.U. Cagliari - Policlinico Universitario Duilio Casula
Address:
City:
Monserrato
Zip:
09042
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Università degli studi di Napoli Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Università della Campania 'Luigi Vanvitelli'
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
AOU Pisana - Stabilimento Santa Chiara
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Policlinico Universitario Campus Bio-Medico
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
AO San Giovanni Addolorata
Address:
City:
Roma
Zip:
00184
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
IRCCS Ospedale Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Zip:
71013
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
AO "Cardinale Giovanni Panico"
Address:
City:
Tricase
Zip:
73039
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
ASU FC - Ospedale "Santa Maria della Misericordia"
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Azienda ULSS 8 Berica - Ospedale San Bortolo
Address:
City:
Vicenza
Zip:
36100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Start date:
December 5, 2023
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05993234
