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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

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-05

Study Completion Date

2027-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HER2-positive Advanced Gastric Cancer HER2-positive Gastroesophageal Junction Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Trastuzumab deruxtecan

Intervention Type DRUG

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.

Interventions

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Trastuzumab deruxtecan

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.

Intervention Type DRUG

Other Intervention Names

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T-DXd ENHERTU®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Team Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Locations

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KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH

Klagenfurt, , Austria

Site Status RECRUITING

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, , Austria

Site Status RECRUITING

Universitätsklinikum St. Pölten - Lilienfeld

Sankt Pölten, , Austria

Site Status RECRUITING

Medizinische Universität Wien

Vienna, , Austria

Site Status RECRUITING

St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe

Vienna, , Austria

Site Status WITHDRAWN

Klinik Ottakring, Wilhelminenspital der Stadt Wien

Vienna, , Austria

Site Status RECRUITING

Kepler Universitätsklinikum

Wels, , Austria

Site Status NOT_YET_RECRUITING

Landesklinikum Wiener Neustadt

Wiener Neustadt, , Austria

Site Status NOT_YET_RECRUITING

Krankenhaus St. Vinzenz in Zams

Zams, , Austria

Site Status RECRUITING

OLV Hospital Aalst

Aalst, , Belgium

Site Status RECRUITING

Imelda vzw

Bonheiden, , Belgium

Site Status RECRUITING

HUB institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Grand hôpital de Charleroi

Charleroi, , Belgium

Site Status RECRUITING

Antwerp University Hospital

Edegem, , Belgium

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

CHU Helora Hospital de La Louvière - Site Jolimont

Haine-Saint-Paul, , Belgium

Site Status RECRUITING

JESSA Hasselt

Hasselt, , Belgium

Site Status RECRUITING

UZ Brussel

Jette, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status WITHDRAWN

MVZ am Klinikum Aschaffenburg

Aschaffenburg, , Germany

Site Status RECRUITING

Universitätsklinikum Augsburg

Augsburg, , Germany

Site Status WITHDRAWN

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Site Status RECRUITING

Charite Campus Benjamin Franklin

Berlin, , Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status RECRUITING

MV-Zentrum für Hämatologie & Onkologie

Cologne, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

University Hospital Essen

Essen, , Germany

Site Status RECRUITING

Universitaetsklinikum Giessen und Marburg, Standort Giessen

Giessen, , Germany

Site Status RECRUITING

Alb Fils Kliniken GmbH

Göppingen, , Germany

Site Status RECRUITING

Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

Hamburg, , Germany

Site Status RECRUITING

Studienzentrum am Raschplatz GbR

Hanover, , Germany

Site Status RECRUITING

KRH Klinikum Siloah

Hanover, , Germany

Site Status RECRUITING

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

Hanover, , Germany

Site Status RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status RECRUITING

ÜBAG MVZ Mitte / MVZ Delitzsch GmbH

Leipzig, , Germany

Site Status RECRUITING

Praxis Hämatologie und Onkologie Magdeburg

Magdeburg, , Germany

Site Status WITHDRAWN

Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie

Magdeburg, , Germany

Site Status RECRUITING

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Site Status RECRUITING

Pi.Tri-Studien GmbH

Offenburg, , Germany

Site Status WITHDRAWN

Klinikum am Steinenberg Reutlingen

Reutlingen, , Germany

Site Status RECRUITING

Nädler GmbH

Rinteln, , Germany

Site Status RECRUITING

CaritasKlinikum Saarbrücken

Saarbrücken, , Germany

Site Status RECRUITING

Praxis Onkologie Rheinsieg

Troisdorf, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg (UKW)

Würzburg, , Germany

Site Status WITHDRAWN

AOU delle Marche

Ancona Torrette, , Italy

Site Status RECRUITING

ASL AT - Presidio Ospedaliero "Cardinal Massaia"

Asti, , Italy

Site Status RECRUITING

IRCCS "S. De Bellis"

Castellana Grotte, , Italy

Site Status RECRUITING

ARNAS Garibaldi - PO Nesima

Catania, , Italy

Site Status RECRUITING

AOU Careggi

Florence, , Italy

Site Status RECRUITING

IRCCS AOU San Martino

Genova, , Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, , Italy

Site Status RECRUITING

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

Monserrato, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, , Italy

Site Status RECRUITING

Università degli studi di Napoli Federico II

Napoli, , Italy

Site Status RECRUITING

Università della Campania 'Luigi Vanvitelli'

Napoli, , Italy

Site Status RECRUITING

AOU Pisana - Stabilimento Santa Chiara

Pisa, , Italy

Site Status RECRUITING

Azienda Sanitaria Locale di Biella - Ospedale degli Infermi

Ponderano, , Italy

Site Status RECRUITING

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

Ravenna, , Italy

Site Status RECRUITING

Policlinico Universitario Campus Bio-Medico

Roma, , Italy

Site Status RECRUITING

AO San Camillo Forlanini

Roma, , Italy

Site Status RECRUITING

AO San Giovanni Addolorata

Roma, , Italy

Site Status RECRUITING

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status RECRUITING

AO "Cardinale Giovanni Panico"

Tricase, , Italy

Site Status RECRUITING

ASU FC - Ospedale "Santa Maria della Misericordia"

Udine, , Italy

Site Status RECRUITING

Azienda ULSS 8 Berica - Ospedale San Bortolo

Vicenza, , Italy

Site Status RECRUITING

ULS Almada-Seixal

Almada, , Portugal

Site Status NOT_YET_RECRUITING

USL Braga

Braga, , Portugal

Site Status NOT_YET_RECRUITING

ULS Coimbra

Coimbra, , Portugal

Site Status NOT_YET_RECRUITING

IPO Lisboa

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

CC Champalimaud

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Hospital da Luz

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

ULS Santo António

Porto, , Portugal

Site Status NOT_YET_RECRUITING

Vila Real

Vila Real, , Portugal

Site Status NOT_YET_RECRUITING

Countries

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Austria Belgium Germany Italy Portugal

Central Contacts

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Contact for Clinical Trial Information

Role: CONTACT

[email protected]
908-992-6400

Facility Contacts

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Other Identifiers

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DS8201-0007-NIS-MA

Identifier Type: -

Identifier Source: org_study_id

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