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Clinical Trials in Germany / NCT05993234
Active, not recruiting Observational

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)

NCT05993234 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2023-12-05
Last updated
2026-08-20

Condition(s) studied

HER2-positive Advanced Gastric CancerHER2-positive Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecan →

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.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Ordensklinikum Linz GmbH Barmherzige Schwestern Linz Austria
Medizinische Universität 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
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
MVZ am Klinikum Aschaffenburg Aschaffenburg Germany
Vivantes Klinikum im Friedrichshain Berlin Germany
Charite Campus Benjamin Franklin Berlin Germany
MV-Zentrum für Hämatologie & Onkologie Cologne Germany
University Hospital Essen Essen 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
Klinikum rechts der Isar der Technischen Universität München München Germany
Klinikum am Steinenberg Reutlingen Reutlingen Germany
CaritasKlinikum Saarbrücken Saarbrücken Germany
Praxis Onkologie Rheinsieg Troisdorf Germany
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
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
AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna Ravenna Italy
Policlinico Universitario Campus Bio-Medico Roma Italy
AO "Cardinale Giovanni Panico" Tricase Italy

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile →

More Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05993234 on ClinicalTrials.gov ↗ ← All trials in Germany