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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trastuzumab deruxtecan.
- Who it may be relevant to
- Registry conditions: HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Germany, Italy, Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [Time frame: Baseline up to approximately 2 years]
Secondary outcome measures (6)
- Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [Time frame: Baseline up to approximately 2 years]
- Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only) [Time frame: Baseline up to approximately 2 years]
- 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) [Time frame: Baseline up to approximately 2 years]
- Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [Time frame: Baseline up to approximately 2 years]
- 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 [Time frame: Baseline up to approximately 2 years]
- 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 [Time frame: Baseline up to approximately 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 25 centers
- MVZ am Klinikum Aschaffenburg — Aschaffenburg
- Universitätsklinikum Augsburg — Augsburg
- Vivantes Klinikum im Friedrichshain — Berlin
- Charite Campus Benjamin Franklin — Berlin
- Klinikum Chemnitz gGmbH — Chemnitz
- MV-Zentrum für Hämatologie & Onkologie — Cologne
- Universitätsklinikum Düsseldorf — Düsseldorf
- University Hospital Essen — Essen
- … and 17 more centers
Italy · 23 centers
- AOU delle Marche — Ancona Torrette
- ASL AT - Presidio Ospedaliero "Cardinal Massaia" — Asti
- IRCCS "S. De Bellis" — Castellana Grotte
- ARNAS Garibaldi - PO Nesima — Catania
- AOU Careggi — Florence
- IRCCS AOU San Martino — Genova
- IRCCS Ospedale San Raffaele — Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- … and 15 more centers
Belgium · 11 centers
- OLV Hospital Aalst — Aalst
- Imelda vzw — Bonheiden
- HUB institut Jules Bordet — Brussels
- Grand hôpital de Charleroi — Charleroi
- Antwerp University Hospital — Edegem
- UZ Gent — Ghent
- CHU Helora Hospital de La Louvière - Site Jolimont — Haine-Saint-Paul
- JESSA Hasselt — Hasselt
- … and 3 more centers
Austria · 9 centers
- KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH — Klagenfurt
- Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz
- Universitätsklinikum St. Pölten - Lilienfeld — Sankt Pölten
- Medizinische Universität Wien — Vienna
- St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe — Vienna
- Klinik Ottakring, Wilhelminenspital der Stadt Wien — Vienna
- Kepler Universitätsklinikum — Wels
- Landesklinikum Wiener Neustadt — Wiener Neustadt
- … and 1 more center
Portugal · 8 centers
- ULS Almada-Seixal — Almada
- USL Braga — Braga
- ULS Coimbra — Coimbra
- IPO Lisboa — Lisbon
- CC Champalimaud — Lisbon
- Hospital da Luz — Lisbon
- ULS Santo António — Porto
- Vila Real — Vila Real
Identifiers
NCT: NCT05993234 · DS8201-0007-NIS-MA