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: November 13, 2024
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Stomach Cancer

Esophageal Disorders

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 am Wörthersee, 9020
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010
    Austria

    Active - Recruiting

  • Universitätsklinikum St. Pölten - Lilienfeld

    St. Pölten, 3100
    Austria

    Active - Recruiting

  • Kepler Universitätsklinikum

    Wels, 4600
    Austria

    Site Not Available

  • Klinik Ottakring, Wilhelminenspital der Stadt Wien

    Wien, 1160
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • 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

  • Krankenhaus St. Vinzenz in Zams

    Zams, 6511
    Austria

    Active - Recruiting

  • OLV Hospital Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • Imelda vzw

    Bonheiden, 1090
    Belgium

    Site Not Available

  • HUB institut Jules Bordet

    Brussels, 1070
    Belgium

    Site Not Available

  • Grand hôpital de Charleroi

    Charleroi, 6000
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • CHU Helora Hospital de La Louvière - Site Jolimont

    Haine-Saint-Paul, 7100
    Belgium

    Site Not Available

  • JESSA Hasselt

    Hasselt, 3500
    Belgium

    Site Not Available

  • UZ Brussel

    Jette, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Charite Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • University Hospital Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Giessen und Marburg, Standort Giessen

    Gießen, 35392
    Germany

    Active - Recruiting

  • Alb Fils Kliniken GmbH

    Göppingen, 73035
    Germany

    Active - Recruiting

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249
    Germany

    Active - Recruiting

  • 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

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • MV-Zentrum für Hämatologie & Onkologie

    Köln, 50677
    Germany

    Active - Recruiting

  • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Praxis Hämatologie und Onkologie Magdeburg

    Magdeburg, 39104
    Germany

    Site Not Available

  • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie

    Magdeburg, 39120
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675
    Germany

    Active - Recruiting

  • Pi.Tri-Studien GmbH

    Offenburg, 77654
    Germany

    Site Not Available

  • Klinikum am Steinenberg Reutlingen

    Reutlingen, 72764
    Germany

    Active - Recruiting

  • Nädler GmbH

    Rinteln, 31737
    Germany

    Site Not Available

  • CaritasKlinikum Saarbrücken

    Saarbrücken, 66113
    Germany

    Active - Recruiting

  • Praxis Onkologie Rheinsieg

    Troisdorf, 53840
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg (UKW)

    Würzburg, 97080
    Germany

    Site Not Available

  • AOU delle Marche

    Ancona Torrette, 60126
    Italy

    Site Not Available

  • ASL AT - Presidio Ospedaliero "Cardinal Massaia"

    Asti, 14100
    Italy

    Site Not Available

  • IRCCS "S. De Bellis"

    Castellana Grotte, 70013
    Italy

    Site Not Available

  • ARNAS Garibaldi - PO Nesima

    Catania, 95122
    Italy

    Site Not Available

  • AOU Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • IRCCS AOU San Martino

    Genova, 16132
    Italy

    Site Not Available

  • 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

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

    Monserrato, 09042
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Università degli studi di Napoli Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Università della Campania 'Luigi Vanvitelli'

    Napoli, 80131
    Italy

    Site Not Available

  • AOU Pisana - Stabilimento Santa Chiara

    Pisa, 56126
    Italy

    Site Not Available

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

    Ravenna, 48121
    Italy

    Site Not Available

  • 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

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • AO "Cardinale Giovanni Panico"

    Tricase, 73039
    Italy

    Site Not Available

  • ASU FC - Ospedale "Santa Maria della Misericordia"

    Udine, 33100
    Italy

    Site Not Available

  • Azienda ULSS 8 Berica - Ospedale San Bortolo

    Vicenza, 36100
    Italy

    Site Not Available

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