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)

Last updated: February 9, 2026
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Gastric Cancer

Digestive System Neoplasms

Treatment

Trastuzumab deruxtecan

Clinical Study ID

NCT05993234
DS8201-0007-NIS-MA
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female adult patient (age ≥ 18 years) with HER2 + advanced gastric or GEJadenocarcinoma who have received a prior trastuzumab based regimen

  • Histological or cytological confirmed diagnosis of advanced HER2 positive gastriccancer or GEJ

  • Documented HER2 + status (archival sample or recent sample prior 2L therapy)

  • Decision to newly initiate monotherapy T-DXd or conventional therapies per SMPCaccording to the physician's choice

  • Written dated and signed Informed Consent (ICF) to participate in the study

Exclusion

Exclusion Criteria:

  • Patients who at time of data collection for this study are participating in or haveparticipated 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.

Study Design

Total Participants: 257
Treatment Group(s): 1
Primary Treatment: Trastuzumab deruxtecan
Phase:
Study Start date:
December 05, 2023
Estimated Completion Date:
September 01, 2027

Study 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.

Connect with a study center

  • KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH

    Klagenfurt 2774326, 9020
    Austria

    Site Not Available

  • KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH

    Klagenfurt am Wörthersee, 9020
    Austria

    Site Not Available

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010
    Austria

    Site Not Available

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz 2772400, 4010
    Austria

    Site Not Available

  • Universitätsklinikum St. Pölten - Lilienfeld

    Sankt Pölten 2766429, 3100
    Austria

    Site Not Available

  • Universitätsklinikum St. Pölten - Lilienfeld

    St. Pölten, 3100
    Austria

    Site Not Available

  • Klinik Ottakring, Wilhelminenspital der Stadt Wien

    Vienna 2761369, 1160
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe

    Vienna 2761369, 1130
    Austria

    Site Not Available

  • Kepler Universitätsklinikum

    Wels, 4600
    Austria

    Site Not Available

  • Kepler Universitätsklinikum

    Wels 2761524, 4600
    Austria

    Site Not Available

  • Klinik Ottakring, Wilhelminenspital der Stadt Wien

    Wien, 1160
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe

    Wien, 1130
    Austria

    Site Not Available

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700
    Austria

    Site Not Available

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt 2761353, 2700
    Austria

    Site Not Available

  • Krankenhaus St. Vinzenz in Zams

    Zams, 6511
    Austria

    Site Not Available

  • Krankenhaus St. Vinzenz in Zams

    Zams 2760749, 6511
    Austria

    Site Not Available

  • OLV Hospital Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • OLV Hospital Aalst

    Aalst 2803448, 9300
    Belgium

    Active - Recruiting

  • Imelda vzw

    Bonheiden, 1090
    Belgium

    Site Not Available

  • Imelda vzw

    Bonheiden 2801539, 1090
    Belgium

    Active - Recruiting

  • HUB institut Jules Bordet

    Brussels, 1070
    Belgium

    Site Not Available

  • HUB institut Jules Bordet

    Brussels 2800866, 1070
    Belgium

    Active - Recruiting

  • Grand hôpital de Charleroi

    Charleroi, 6000
    Belgium

    Site Not Available

  • Grand hôpital de Charleroi

    Charleroi 2800481, 6000
    Belgium

    Active - Recruiting

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem 2799007, 2650
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent 2797656, 9000
    Belgium

    Active - Recruiting

  • CHU Helora Hospital de La Louvière - Site Jolimont

    Haine-Saint-Paul, 7100
    Belgium

    Site Not Available

  • CHU Helora Hospital de La Louvière - Site Jolimont

    Haine-Saint-Paul 2796737, 7100
    Belgium

    Active - Recruiting

  • JESSA Hasselt

    Hasselt, 3500
    Belgium

    Site Not Available

  • JESSA Hasselt

    Hasselt 2796491, 3500
    Belgium

    Active - Recruiting

  • UZ Brussel

    Jette, 3000
    Belgium

    Site Not Available

  • UZ Brussel

    Jette 2794914, 3000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare 2787889, 8800
    Belgium

    Site Not Available

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg 2955272, 63739
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg 2954172, 86156
    Germany

    Site Not Available

  • Charite Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249
    Germany

    Site Not Available

  • Charite Campus Benjamin Franklin

    Berlin 2950159, 12203
    Germany

    Site Not Available

  • Vivantes Klinikum im Friedrichshain

    Berlin 2950159, 10249
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz 2940132, 09116
    Germany

    Site Not Available

  • MV-Zentrum für Hämatologie & Onkologie

    Cologne 2886242, 50677
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf 2934246, 40225
    Germany

    Site Not Available

  • University Hospital Essen

    Essen, 45147
    Germany

    Site Not Available

  • University Hospital Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen und Marburg, Standort Giessen

    Giessen 2920512, 35392
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen und Marburg, Standort Giessen

    Gießen, 35392
    Germany

    Site Not Available

  • Alb Fils Kliniken GmbH

    Göppingen, 73035
    Germany

    Site Not Available

  • Alb Fils Kliniken GmbH

    Göppingen 2919054, 73035
    Germany

    Site Not Available

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249
    Germany

    Site Not Available

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg 2911298, 20249
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn

    Hannover, 30625
    Germany

    Active - Recruiting

  • KRH Klinikum Siloah

    Hannover, 30459
    Germany

    Site Not Available

  • Studienzentrum am Raschplatz GbR

    Hannover, 30161
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn

    Hanover 2910831, 30625
    Germany

    Site Not Available

  • KRH Klinikum Siloah

    Hanover 2910831, 30459
    Germany

    Site Not Available

  • Studienzentrum am Raschplatz GbR

    Hanover 2910831, 30161
    Germany

    Site Not Available

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Städtisches Klinikum Karlsruhe

    Karlsruhe 2892794, 76133
    Germany

    Site Not Available

  • MV-Zentrum für Hämatologie & Onkologie

    Köln, 50677
    Germany

    Site Not Available

  • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH

    Leipzig, 04103
    Germany

    Site Not Available

  • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • Praxis Hämatologie und Onkologie Magdeburg

    Magdeburg, 39104
    Germany

    Site Not Available

  • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie

    Magdeburg, 39120
    Germany

    Site Not Available

  • Praxis Hämatologie und Onkologie Magdeburg

    Magdeburg 2874545, 39104
    Germany

    Site Not Available

  • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie

    Magdeburg 2874545, 39120
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität München

    München 2867711, 81675
    Germany

    Site Not Available

  • Pi.Tri-Studien GmbH

    Offenburg, 77654
    Germany

    Site Not Available

  • Pi.Tri-Studien GmbH

    Offenburg 2857798, 77654
    Germany

    Site Not Available

  • Klinikum am Steinenberg Reutlingen

    Reutlingen, 72764
    Germany

    Site Not Available

  • Klinikum am Steinenberg Reutlingen

    Reutlingen 2847736, 72764
    Germany

    Site Not Available

  • Nädler GmbH

    Rinteln, 31737
    Germany

    Site Not Available

  • Nädler GmbH

    Rinteln 2846523, 31737
    Germany

    Site Not Available

  • CaritasKlinikum Saarbrücken

    Saarbrücken, 66113
    Germany

    Site Not Available

  • CaritasKlinikum Saarbrücken

    Saarbrücken 2842647, 66113
    Germany

    Site Not Available

  • Praxis Onkologie Rheinsieg

    Troisdorf, 53840
    Germany

    Site Not Available

  • Praxis Onkologie Rheinsieg

    Troisdorf 2821029, 53840
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg (UKW)

    Würzburg, 97080
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg (UKW)

    Würzburg 2805615, 97080
    Germany

    Site Not Available

  • AOU delle Marche

    Ancona Torrette, 60126
    Italy

    Active - Recruiting

  • ASL AT - Presidio Ospedaliero "Cardinal Massaia"

    Asti, 14100
    Italy

    Site Not Available

  • ASL AT - Presidio Ospedaliero "Cardinal Massaia"

    Asti 3182714, 14100
    Italy

    Active - Recruiting

  • IRCCS "S. De Bellis"

    Castellana Grotte, 70013
    Italy

    Site Not Available

  • IRCCS "S. De Bellis"

    Castellana Grotte 3179656, 70013
    Italy

    Active - Recruiting

  • ARNAS Garibaldi - PO Nesima

    Catania, 95122
    Italy

    Site Not Available

  • ARNAS Garibaldi - PO Nesima

    Catania 2525068, 95122
    Italy

    Active - Recruiting

  • AOU Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • AOU Careggi

    Florence 3176959, 50134
    Italy

    Active - Recruiting

  • IRCCS AOU San Martino

    Genova, 16132
    Italy

    Site Not Available

  • IRCCS AOU San Martino

    Genova 8969657, 16132
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan 6951411, 20132
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena

    Modena 3173331, 41124
    Italy

    Active - Recruiting

  • A.O.U. Cagliari - Policlinico Universitario Duilio Casula

    Monserrato, 09042
    Italy

    Site Not Available

  • A.O.U. Cagliari - Policlinico Universitario Duilio Casula

    Monserrato 2524084, 09042
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Università degli studi di Napoli Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Università della Campania 'Luigi Vanvitelli'

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Università degli studi di Napoli Federico II

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Università della Campania 'Luigi Vanvitelli'

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • AOU Pisana - Stabilimento Santa Chiara

    Pisa, 56126
    Italy

    Site Not Available

  • AOU Pisana - Stabilimento Santa Chiara

    Pisa 3170647, 56126
    Italy

    Active - Recruiting

  • Azienda Sanitaria Locale di Biella - Ospedale degli Infermi

    Ponderano, 13875
    Italy

    Site Not Available

  • Azienda Sanitaria Locale di Biella - Ospedale degli Infermi

    Ponderano 6535682, 13875
    Italy

    Active - Recruiting

  • AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna

    Ravenna, 48121
    Italy

    Site Not Available

  • AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna

    Ravenna 3169561, 48121
    Italy

    Active - Recruiting

  • AO San Camillo Forlanini

    Roma, 00182
    Italy

    Site Not Available

  • AO San Giovanni Addolorata

    Roma, 00184
    Italy

    Site Not Available

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128
    Italy

    Site Not Available

  • AO San Camillo Forlanini

    Roma 8957247, 00182
    Italy

    Active - Recruiting

  • AO San Giovanni Addolorata

    Roma 8957247, 00184
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Bio-Medico

    Roma 8957247, 00128
    Italy

    Active - Recruiting

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo 3168234, 71013
    Italy

    Active - Recruiting

  • AO "Cardinale Giovanni Panico"

    Tricase, 73039
    Italy

    Site Not Available

  • AO "Cardinale Giovanni Panico"

    Tricase 2522857, 73039
    Italy

    Active - Recruiting

  • ASU FC - Ospedale "Santa Maria della Misericordia"

    Udine, 33100
    Italy

    Site Not Available

  • ASU FC - Ospedale "Santa Maria della Misericordia"

    Udine 3165072, 33100
    Italy

    Active - Recruiting

  • Azienda ULSS 8 Berica - Ospedale San Bortolo

    Vicenza, 36100
    Italy

    Site Not Available

  • Azienda ULSS 8 Berica - Ospedale San Bortolo

    Vicenza 3164419, 36100
    Italy

    Active - Recruiting

  • ULS Almada-Seixal

    Almada 2271961, 2805-267
    Portugal

    Site Not Available

  • USL Braga

    Braga 2742032, 4710-243
    Portugal

    Site Not Available

  • ULS Coimbra

    Coimbra 2740637, 3004-561
    Portugal

    Site Not Available

  • CC Champalimaud

    Lisbon 2267057, 1400-038
    Portugal

    Site Not Available

  • Hospital da Luz

    Lisbon 2267057, 1500-650
    Portugal

    Site Not Available

  • IPO Lisboa

    Lisbon 2267057, 1099-023
    Portugal

    Site Not Available

  • ULS Santo António

    Porto 2735943, 4050-342
    Portugal

    Site Not Available

  • Vila Real

    Vila Real 2732438, 5000-508
    Portugal

    Active - Recruiting

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