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)

NCT05993234 | Active Not Recruiting FDA Drug

• 1 other identifier: DS8201-0007-NIS-MA
• Study Type: observational
• Target: 257
• Locations: 4 countries
• Sites: 39

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.

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®

Outcome Measures

Primary Outcomes (1)

• Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

  Baseline up to approximately 2 years

Secondary Outcomes (6)

• Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

  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)

  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)

  Baseline up to approximately 2 years

• Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

  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

  Baseline up to approximately 2 years

Study Arms (1)

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

Interventions

Trastuzumab deruxtecan DRUG

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.

Also known as: T-DXd, ENHERTU®

Trastuzumab deruxtecan (T-DXd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company: lead

Study Sites (39)

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, 4010, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Kepler Universitätsklinikum

Wels, 4600, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Krankenhaus St. Vinzenz in Zams

Zams, 6511, Austria

Location

OLV Hospital Aalst

Aalst, 9300, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU Helora Hospital de La Louvière - Site Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

JESSA Hasselt

Hasselt, 3500, Belgium

Location

UZ Brussel

Jette, 3000, Belgium

Location

MVZ am Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Charite Campus Benjamin Franklin

Berlin, 12203, Germany

Location

MV-Zentrum für Hämatologie & Onkologie

Cologne, 50677, Germany

Location

University Hospital Essen

Essen, 45147, Germany

Location

Alb Fils Kliniken GmbH

Göppingen, 73035, Germany

Location

Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

Hamburg, 20249, Germany

Location

Studienzentrum am Raschplatz GbR

Hanover, 30161, Germany

Location

KRH Klinikum Siloah

Hanover, 30459, Germany

Location

Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn

Hanover, 30625, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

Location

Klinikum am Steinenberg Reutlingen

Reutlingen, 72764, Germany

Location

CaritasKlinikum Saarbrücken

Saarbrücken, 66113, Germany

Location

Praxis Onkologie Rheinsieg

Troisdorf, 53840, Germany

Location

IRCCS "S. De Bellis"

Castellana Grotte, 70013, Italy

Location

ARNAS Garibaldi - PO Nesima

Catania, 95122, Italy

Location

AOU Careggi

Florence, 50134, Italy

Location

IRCCS AOU San Martino

Genova, 16132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Azienda Ospedaliero-Universitaria di Modena

Modena, 41124, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, 80131, Italy

Location

Università degli studi di Napoli Federico II

Naples, 80131, Italy

Location

Università della Campania 'Luigi Vanvitelli'

Naples, 80131, Italy

Location

AOU Pisana - Stabilimento Santa Chiara

Pisa, 56126, Italy

Location

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

Ravenna, 48121, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

AO "Cardinale Giovanni Panico"

Tricase, 73039, Italy

Location

MeSH Terms

Interventions

trastuzumab deruxtecan

Study Officials

• Global Team Leader

  Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 15, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (14); AU (5); BE (6); DE (14)