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)
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)
1 other identifier
observational
257
5 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Typical duration for all trials
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 12, 2026
February 1, 2026
3 years
August 2, 2023
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline up to approximately 2 years
Secondary Outcomes (6)
Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline up to approximately 2 years
Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)
Baseline up to approximately 2 years
Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)
Baseline up to approximately 2 years
Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline up to approximately 2 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline up to approximately 2 years
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH
Klagenfurt, 9020, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010, Austria
Universitätsklinikum St. Pölten - Lilienfeld
Sankt Pölten, 3100, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe
Vienna, 1130, Austria
Klinik Ottakring, Wilhelminenspital der Stadt Wien
Vienna, 1160, Austria
Kepler Universitätsklinikum
Wels, 4600, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700, Austria
Krankenhaus St. Vinzenz in Zams
Zams, 6511, Austria
OLV Hospital Aalst
Aalst, 9300, Belgium
Imelda vzw
Bonheiden, 1090, Belgium
HUB institut Jules Bordet
Brussels, 1070, Belgium
Grand hôpital de Charleroi
Charleroi, 6000, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
CHU Helora Hospital de La Louvière - Site Jolimont
Haine-Saint-Paul, 7100, Belgium
JESSA Hasselt
Hasselt, 3500, Belgium
UZ Brussel
Jette, 3000, Belgium
UZ Leuven
Leuven, 3000, Belgium
AZ Delta
Roeselare, 8800, Belgium
MVZ am Klinikum Aschaffenburg
Aschaffenburg, 63739, Germany
Universitätsklinikum Augsburg
Augsburg, 86156, Germany
Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Charite Campus Benjamin Franklin
Berlin, 12203, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
MV-Zentrum für Hämatologie & Onkologie
Cologne, 50677, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
University Hospital Essen
Essen, 45147, Germany
Universitaetsklinikum Giessen und Marburg, Standort Giessen
Giessen, 35392, Germany
Alb Fils Kliniken GmbH
Göppingen, 73035, Germany
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
Hamburg, 20249, Germany
Studienzentrum am Raschplatz GbR
Hanover, 30161, Germany
KRH Klinikum Siloah
Hanover, 30459, Germany
Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
Hanover, 30625, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133, Germany
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH
Leipzig, 04103, Germany
Praxis Hämatologie und Onkologie Magdeburg
Magdeburg, 39104, Germany
Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
Magdeburg, 39120, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Pi.Tri-Studien GmbH
Offenburg, 77654, Germany
Klinikum am Steinenberg Reutlingen
Reutlingen, 72764, Germany
Nädler GmbH
Rinteln, 31737, Germany
CaritasKlinikum Saarbrücken
Saarbrücken, 66113, Germany
Praxis Onkologie Rheinsieg
Troisdorf, 53840, Germany
Universitätsklinikum Würzburg (UKW)
Würzburg, 97080, Germany
AOU delle Marche
Ancona Torrette, 60126, Italy
ASL AT - Presidio Ospedaliero "Cardinal Massaia"
Asti, 14100, Italy
IRCCS "S. De Bellis"
Castellana Grotte, 70013, Italy
ARNAS Garibaldi - PO Nesima
Catania, 95122, Italy
AOU Careggi
Florence, 50134, Italy
IRCCS AOU San Martino
Genova, 16132, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124, Italy
A.O.U. Cagliari - Policlinico Universitario Duilio Casula
Monserrato, 09042, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131, Italy
Università degli studi di Napoli Federico II
Naples, 80131, Italy
Università della Campania 'Luigi Vanvitelli'
Naples, 80131, Italy
AOU Pisana - Stabilimento Santa Chiara
Pisa, 56126, Italy
Azienda Sanitaria Locale di Biella - Ospedale degli Infermi
Ponderano, 13875, Italy
AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna
Ravenna, 48121, Italy
Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
AO San Camillo Forlanini
Roma, 00182, Italy
AO San Giovanni Addolorata
Roma, 00184, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
AO "Cardinale Giovanni Panico"
Tricase, 73039, Italy
ASU FC - Ospedale "Santa Maria della Misericordia"
Udine, 33100, Italy
Azienda ULSS 8 Berica - Ospedale San Bortolo
Vicenza, 36100, Italy
ULS Almada-Seixal
Almada, 2805-267, Portugal
USL Braga
Braga, 4710-243, Portugal
ULS Coimbra
Coimbra, 3004-561, Portugal
IPO Lisboa
Lisbon, 1099-023, Portugal
CC Champalimaud
Lisbon, 1400-038, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
ULS Santo António
Porto, 4050-342, Portugal
Vila Real
Vila Real, 5000-508, Portugal
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Global Team Leader
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2023
First Posted
August 15, 2023
Study Start
December 5, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share