RecruitingNCT05993234

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)


Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Enrollment

257 participants

Start Date

Dec 5, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes for patients with HER2-positive advanced stomach or esophageal cancer who receive a drug called trastuzumab deruxtecan (T-DXd) after a prior trastuzumab-based treatment stopped working. It also includes a separate group receiving standard chemotherapy for comparison. **You may be eligible if...** - You are 18 years or older - You have HER2-positive advanced stomach or gastroesophageal junction (where the stomach meets the esophagus) cancer - You have already received a trastuzumab-based treatment regimen - Your HER2-positive status has been confirmed by laboratory tests - Your doctor has decided to start you on T-DXd or conventional therapy **You may NOT be eligible if...** - You have not received prior trastuzumab-based therapy - Your HER2 status has not been confirmed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab 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.


Locations(76)

KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH

Klagenfurt, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Austria

Universitätsklinikum St. Pölten - Lilienfeld

Sankt Pölten, Austria

Medizinische Universität Wien

Vienna, Austria

St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe

Vienna, Austria

Klinik Ottakring, Wilhelminenspital der Stadt Wien

Vienna, Austria

Kepler Universitätsklinikum

Wels, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

Krankenhaus St. Vinzenz in Zams

Zams, Austria

OLV Hospital Aalst

Aalst, Belgium

Imelda vzw

Bonheiden, Belgium

HUB institut Jules Bordet

Brussels, Belgium

Grand hôpital de Charleroi

Charleroi, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Gent

Ghent, Belgium

CHU Helora Hospital de La Louvière - Site Jolimont

Haine-Saint-Paul, Belgium

JESSA Hasselt

Hasselt, Belgium

UZ Brussel

Jette, Belgium

UZ Leuven

Leuven, Belgium

AZ Delta

Roeselare, Belgium

MVZ am Klinikum Aschaffenburg

Aschaffenburg, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Vivantes Klinikum im Friedrichshain

Berlin, Germany

Charite Campus Benjamin Franklin

Berlin, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

MV-Zentrum für Hämatologie & Onkologie

Cologne, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

University Hospital Essen

Essen, Germany

Universitaetsklinikum Giessen und Marburg, Standort Giessen

Giessen, Germany

Alb Fils Kliniken GmbH

Göppingen, Germany

Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

Hamburg, Germany

Studienzentrum am Raschplatz GbR

Hanover, Germany

KRH Klinikum Siloah

Hanover, Germany

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

Hanover, Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

ÜBAG MVZ Mitte / MVZ Delitzsch GmbH

Leipzig, Germany

Praxis Hämatologie und Onkologie Magdeburg

Magdeburg, Germany

Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie

Magdeburg, Germany

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Pi.Tri-Studien GmbH

Offenburg, Germany

Klinikum am Steinenberg Reutlingen

Reutlingen, Germany

Nädler GmbH

Rinteln, Germany

CaritasKlinikum Saarbrücken

Saarbrücken, Germany

Praxis Onkologie Rheinsieg

Troisdorf, Germany

Universitätsklinikum Würzburg (UKW)

Würzburg, Germany

AOU delle Marche

Ancona Torrette, Italy

ASL AT - Presidio Ospedaliero "Cardinal Massaia"

Asti, Italy

IRCCS "S. De Bellis"

Castellana Grotte, Italy

ARNAS Garibaldi - PO Nesima

Catania, Italy

AOU Careggi

Florence, Italy

IRCCS AOU San Martino

Genova, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

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

Monserrato, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Università degli studi di Napoli Federico II

Naples, Italy

Università della Campania 'Luigi Vanvitelli'

Naples, Italy

AOU Pisana - Stabilimento Santa Chiara

Pisa, Italy

Azienda Sanitaria Locale di Biella - Ospedale degli Infermi

Ponderano, Italy

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

Ravenna, Italy

Policlinico Universitario Campus Bio-Medico

Roma, Italy

AO San Camillo Forlanini

Roma, Italy

AO San Giovanni Addolorata

Roma, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

AO "Cardinale Giovanni Panico"

Tricase, Italy

ASU FC - Ospedale "Santa Maria della Misericordia"

Udine, Italy

Azienda ULSS 8 Berica - Ospedale San Bortolo

Vicenza, Italy

ULS Almada-Seixal

Almada, Portugal

USL Braga

Braga, Portugal

ULS Coimbra

Coimbra, Portugal

IPO Lisboa

Lisbon, Portugal

CC Champalimaud

Lisbon, Portugal

Hospital da Luz

Lisbon, Portugal

ULS Santo António

Porto, Portugal

Vila Real

Vila Real, Portugal

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NCT05993234


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