Clinical trial NCT05993234: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Advanced Gastric Cancer
HER2-positive Gastroesophageal Junction Adenocarcinoma
Keywords: HER2-positive Advanced Gastric Cancer
HER2-positive Gastroesophageal Junction Adenocarcinoma
Trastuzumab Deruxtecan
Conventional therapy
ENHERTU®
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with advanced HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen in a real-world setting in Europe.

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
timeFrame: Baseline up to approximately 2 years
Secondary outcomes:
measure: Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
timeFrame: Baseline up to approximately 2 years
measure: Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)
timeFrame: Baseline up to approximately 2 years
measure: Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)
timeFrame: Baseline up to approximately 2 years
measure: Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
timeFrame: Baseline up to approximately 2 years
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
timeFrame: Baseline up to approximately 2 years
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach (EORTC QLQ-STO22) Score in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
timeFrame: Baseline up to approximately 2 years
Other outcomes:
Locations:
city: Klagenfurt am Wörthersee
country: Austria
facility: KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten - Lilienfeld
city: Wels
country: Austria
facility: Kepler Universitätsklinikum
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe
city: Wien
country: Austria
facility: Klinik Ottakring, Wilhelminenspital der Stadt Wien
city: Zams
country: Austria
facility: Krankenhaus St. Vinzenz in Zams
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
city: Bonheiden
country: Belgium
facility: Imelda vzw
city: Brussels
country: Belgium
facility: HUB institut Jules Bordet
city: Charleroi
country: Belgium
facility: Grand hôpital de Charleroi
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Gent
country: Belgium
facility: UZ Gent
city: Haine-Saint-Paul
country: Belgium
facility: CHU Helora Hospital de La Louvière - Site Jolimont
city: Hasselt
country: Belgium
facility: JESSA Hasselt
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: Aschaffenburg
country: Germany
facility: MVZ am Klinikum Aschaffenburg
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: University Hospital Essen
city: Gießen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg, Standort Giessen
city: Göppingen
country: Germany
facility: Alb Fils Kliniken GmbH
city: Hamburg
country: Germany
facility: Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
city: Hannover
country: Germany
facility: Studienzentrum am Raschplatz GbR
city: Hannover
country: Germany
facility: KRH Klinikum Siloah
city: Hannover
country: Germany
facility: Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Köln
country: Germany
facility: MV-Zentrum für Hämatologie & Onkologie
city: Leipzig
country: Germany
facility: ÜBAG MVZ Mitte / MVZ Delitzsch GmbH
city: Magdeburg
country: Germany
facility: Praxis Hämatologie und Onkologie Magdeburg
city: Magdeburg
country: Germany
facility: Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Offenburg
country: Germany
facility: Pi.Tri-Studien GmbH
city: Reutlingen
country: Germany
facility: Klinikum am Steinenberg Reutlingen
city: Rinteln
country: Germany
facility: Nädler GmbH
city: Saarbrücken
country: Germany
facility: CaritasKlinikum Saarbrücken
city: Troisdorf
country: Germany
facility: Praxis Onkologie Rheinsieg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg (UKW)
city: Ancona Torrette
country: Italy
facility: AOU delle Marche
city: Asti
country: Italy
facility: ASL AT - Presidio Ospedaliero "Cardinal Massaia"
city: Castellana Grotte
country: Italy
facility: IRCCS "S. De Bellis"
city: Catania
country: Italy
facility: ARNAS Garibaldi - PO Nesima
city: Firenze
country: Italy
facility: AOU Careggi
city: Genova
country: Italy
facility: IRCCS AOU San Martino
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Monserrato
country: Italy
facility: A.O.U. Cagliari - Policlinico Universitario Duilio Casula
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Napoli
country: Italy
facility: Università degli studi di Napoli Federico II
city: Napoli
country: Italy
facility: Università della Campania 'Luigi Vanvitelli'
city: Pisa
country: Italy
facility: AOU Pisana - Stabilimento Santa Chiara
city: Ponderano
country: Italy
facility: Azienda Sanitaria Locale di Biella - Ospedale degli Infermi
city: Ravenna
country: Italy
facility: AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: AO San Camillo Forlanini
city: Roma
country: Italy
facility: AO San Giovanni Addolorata
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Tricase
country: Italy
facility: AO "Cardinale Giovanni Panico"
city: Udine
country: Italy
facility: ASU FC - Ospedale "Santa Maria della Misericordia"
city: Vicenza
country: Italy
facility: Azienda ULSS 8 Berica - Ospedale San Bortolo
Study officials:
affiliation: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
name: Global Team Leader
role: STUDY_DIRECTOR
References: