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)
- Conditions
- HER2-positive Gastroesophageal Junction AdenocarcinomaHER2-positive Advanced Gastric Cancer
- Interventions
- Registration Number
- NCT05993234
- Lead Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 257
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trastuzumab deruxtecan (T-DXd) Trastuzumab deruxtecan 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.
- Primary Outcome Measures
Name Time Method Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma Baseline up to approximately 2 years
- Secondary Outcome Measures
Name Time Method 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 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 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 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).
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 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)
Trial Locations
- Locations (68)
MVZ am Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Charite Campus Benjamin Franklin
🇩🇪Berlin, Germany
Studienzentrum am Raschplatz GbR
🇩🇪Hannover, Germany
KRH Klinikum Siloah
🇩🇪Hannover, Germany
Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn
🇩🇪Hannover, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
MV-Zentrum für Hämatologie & Onkologie
🇩🇪Köln, Germany
Azienda Sanitaria Locale di Biella - Ospedale degli Infermi
🇮🇹Ponderano, Italy
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH
🇩🇪Leipzig, Germany
Praxis Hämatologie und Onkologie Magdeburg
🇩🇪Magdeburg, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Klinikum am Steinenberg Reutlingen
🇩🇪Reutlingen, Germany
Nädler GmbH
🇩🇪Rinteln, Germany
Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
🇩🇪Magdeburg, Germany
CaritasKlinikum Saarbrücken
🇩🇪Saarbrücken, Germany
Praxis Onkologie Rheinsieg
🇩🇪Troisdorf, Germany
Universitätsklinikum Würzburg (UKW)
🇩🇪Würzburg, Germany
AOU delle Marche
🇮🇹Ancona Torrette, Italy
ASL AT - Presidio Ospedaliero "Cardinal Massaia"
🇮🇹Asti, Italy
IRCCS "S. De Bellis"
🇮🇹Castellana Grotte, Italy
ARNAS Garibaldi - PO Nesima
🇮🇹Catania, Italy
AOU Careggi
🇮🇹Firenze, Italy
IRCCS AOU San Martino
🇮🇹Genova, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH
🇦🇹Klagenfurt am Wörthersee, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
🇦🇹Linz, Austria
Universitätsklinikum St. Pölten - Lilienfeld
🇦🇹St. Pölten, Austria
Kepler Universitätsklinikum
🇦🇹Wels, Austria
Landesklinikum Wiener Neustadt
🇦🇹Wiener Neustadt, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe
🇦🇹Wien, Austria
Klinik Ottakring, Wilhelminenspital der Stadt Wien
🇦🇹Wien, Austria
Krankenhaus St. Vinzenz in Zams
🇦🇹Zams, Austria
Imelda vzw
🇧🇪Bonheiden, Belgium
OLV Hospital Aalst
🇧🇪Aalst, Belgium
University Hospital Essen
🇩🇪Essen, Germany
Universitaetsklinikum Giessen und Marburg, Standort Giessen
🇩🇪Gießen, Germany
Alb Fils Kliniken GmbH
🇩🇪Göppingen, Germany
HUB institut Jules Bordet
🇧🇪Brussels, Belgium
Grand hôpital de Charleroi
🇧🇪Charleroi, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
CHU Helora Hospital de La Louvière - Site Jolimont
🇧🇪Haine-Saint-Paul, Belgium
JESSA Hasselt
🇧🇪Hasselt, Belgium
UZ Brussel
🇧🇪Jette, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
🇩🇪Hamburg, Germany
Klinikum rechts der Isar der Technischen Universität München
🇩🇪München, Germany
Pi.Tri-Studien GmbH
🇩🇪Offenburg, Germany
AZ Delta
🇧🇪Roeselare, Belgium
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria di Modena
🇮🇹Modena, Italy
A.O.U. Cagliari - Policlinico Universitario Duilio Casula
🇮🇹Monserrato, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
🇮🇹Napoli, Italy
Università degli studi di Napoli Federico II
🇮🇹Napoli, Italy
Università della Campania 'Luigi Vanvitelli'
🇮🇹Napoli, Italy
AOU Pisana - Stabilimento Santa Chiara
🇮🇹Pisa, Italy
AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna
🇮🇹Ravenna, Italy
Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Italy
AO San Camillo Forlanini
🇮🇹Roma, Italy
AO San Giovanni Addolorata
🇮🇹Roma, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
AO "Cardinale Giovanni Panico"
🇮🇹Tricase, Italy
ASU FC - Ospedale "Santa Maria della Misericordia"
🇮🇹Udine, Italy
Azienda ULSS 8 Berica - Ospedale San Bortolo
🇮🇹Vicenza, Italy