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RECRUITINGOBSERVATIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form (ICF) to participate in the study Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

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.

Locations (20)

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