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)

August 18, 2026 updated by: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
      • Wels, Austria, 4600
        • Kepler Universitätsklinikum
      • Wiener Neustadt, Austria, 2700
        • Landesklinikum Wiener Neustadt
      • Zams, Austria, 6511
        • Krankenhaus St. Vinzenz in Zams
  • Belgium
      • Aalst, Belgium, 9300
        • OLV Hospital Aalst
      • Edegem, Belgium, 2650
        • Antwerp University Hospital
      • Ghent, Belgium, 9000
        • UZ Gent
      • Haine-Saint-Paul, Belgium, 7100
        • CHU Helora Hospital de La Louvière - Site Jolimont
      • Hasselt, Belgium, 3500
        • JESSA Hasselt
      • Jette, Belgium, 3000
        • UZ Brussel
  • Germany
      • Aschaffenburg, Germany, 63739
        • MVZ am Klinikum Aschaffenburg
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain
      • Cologne, Germany, 50677
        • MV-Zentrum für Hämatologie & Onkologie
      • Essen, Germany, 45147
        • University Hospital Essen
      • Göppingen, Germany, 73035
        • Alb Fils Kliniken GmbH
      • Hamburg, Germany, 20249
        • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
      • Hanover, Germany, 30459
        • KRH Klinikum Siloah
      • Hanover, Germany, 30161
        • Studienzentrum am Raschplatz GbR
      • Hanover, Germany, 30625
        • Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
      • München, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • Reutlingen, Germany, 72764
        • Klinikum am Steinenberg Reutlingen
      • Saarbrücken, Germany, 66113
        • CaritasKlinikum Saarbrücken
      • Troisdorf, Germany, 53840
        • Praxis Onkologie Rheinsieg
  • Italy
      • Castellana Grotte, Italy, 70013
        • IRCCS "S. De Bellis"
      • Catania, Italy, 95122
        • ARNAS Garibaldi - PO Nesima
      • Florence, Italy, 50134
        • AOU Careggi
      • Genova, Italy, 16132
        • IRCCS AOU San Martino
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena
      • Naples, Italy, 80131
        • Università della Campania 'Luigi Vanvitelli'
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
      • Naples, Italy, 80131
        • Università Degli Studi Di Napoli Federico Ii
      • Pisa, Italy, 56126
        • AOU Pisana - Stabilimento Santa Chiara
      • Ravenna, Italy, 48121
        • AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Tricase, Italy, 73039
        • AO "Cardinale Giovanni Panico"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trastuzumab deruxtecan (T-DXd)
Participants with HER2-positive gastric or gastroesophageal junction adenocarcinoma who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional therapy. The participants on conventional therapy will be analyzed for exploratory purposes only.
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.

Other Names:
  • T-DXd
  • ENHERTU®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
The EORTC QLQ-C30 questionnaire is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
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
The EORTC QLQ-STO22 is a gastric cancer-specific module which has been developed to measure the quality of life in patients with gastric cancer. The gastric cancer specific questions on the EORTC QLQ-STO22 include four single-item subscales (dry mouth, body image, hair loss and problems with taste) and five multi-item subscales (dysphagia, dietary restriction, pain, upper gastroesophageal symptoms and emotional problems). The EORTC QLQ single-item and multi-item scales range in score from 0 to 100. A higher score on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient)
Baseline up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Investigators

  • Study Director: Global Team Leader, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-0007-NIS-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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