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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Baseline up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Contact | 908-992-6400 | CTRinfo@dsi.com |
| Name | Affiliation | Role |
|---|---|---|
| Global Team Leader | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH | Withdrawn | Klagenfurt | 9020 | Austria | ||
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|
|
| 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 | 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 | 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 |
| Ordensklinikum Linz GmbH Barmherzige Schwestern |
| Active, not recruiting |
| Linz |
| 4010 |
| Austria |
| Universitätsklinikum St. Pölten - Lilienfeld | Withdrawn | Sankt Pölten | 3100 | Austria |
| Medizinische Universität Wien | Active, not recruiting | Vienna | 1090 | Austria |
| St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe | Withdrawn | Vienna | 1130 | Austria |
| Klinik Ottakring, Wilhelminenspital der Stadt Wien | Withdrawn | Vienna | 1160 | Austria |
| Kepler Universitätsklinikum | Active, not recruiting | Wels | 4600 | Austria |
| Landesklinikum Wiener Neustadt | Active, not recruiting | Wiener Neustadt | 2700 | Austria |
| Krankenhaus St. Vinzenz in Zams | Active, not recruiting | Zams | 6511 | Austria |
| OLV Hospital Aalst | Active, not recruiting | Aalst | 9300 | Belgium |
| Imelda vzw | Withdrawn | Bonheiden | 1090 | Belgium |
| HUB institut Jules Bordet | Withdrawn | Brussels | 1070 | Belgium |
| Grand hôpital de Charleroi | Withdrawn | Charleroi | 6000 | Belgium |
| Antwerp University Hospital | Active, not recruiting | Edegem | 2650 | Belgium |
| UZ Gent | Active, not recruiting | Ghent | 9000 | Belgium |
| CHU Helora Hospital de La Louvière - Site Jolimont | Active, not recruiting | Haine-Saint-Paul | 7100 | Belgium |
| JESSA Hasselt | Active, not recruiting | Hasselt | 3500 | Belgium |
| UZ Brussel | Active, not recruiting | Jette | 3000 | Belgium |
| UZ Leuven | Withdrawn | Leuven | 3000 | Belgium |
| AZ Delta | Withdrawn | Roeselare | 8800 | Belgium |
| MVZ am Klinikum Aschaffenburg | Active, not recruiting | Aschaffenburg | 63739 | Germany |
| Universitätsklinikum Augsburg | Withdrawn | Augsburg | 86156 | Germany |
| Vivantes Klinikum im Friedrichshain | Active, not recruiting | Berlin | 10249 | Germany |
| Charite Campus Benjamin Franklin | Active, not recruiting | Berlin | 12203 | Germany |
| Klinikum Chemnitz gGmbH | Withdrawn | Chemnitz | 09116 | Germany |
| MV-Zentrum für Hämatologie & Onkologie | Active, not recruiting | Cologne | 50677 | Germany |
| Universitätsklinikum Düsseldorf | Withdrawn | Düsseldorf | 40225 | Germany |
| University Hospital Essen | Active, not recruiting | Essen | 45147 | Germany |
| Universitaetsklinikum Giessen und Marburg, Standort Giessen | Withdrawn | Giessen | 35392 | Germany |
| Alb Fils Kliniken GmbH | Active, not recruiting | Göppingen | 73035 | Germany |
| Hämatologisch-Onkologische Praxis Eppendorf (HOPE) | Active, not recruiting | Hamburg | 20249 | Germany |
| Studienzentrum am Raschplatz GbR | Active, not recruiting | Hanover | 30161 | Germany |
| KRH Klinikum Siloah | Active, not recruiting | Hanover | 30459 | Germany |
| Gemeinschaftspraxis Dr. Haytham Kamal / Dr. David C. Dorn | Active, not recruiting | Hanover | 30625 | Germany |
| Städtisches Klinikum Karlsruhe | Withdrawn | Karlsruhe | 76133 | Germany |
| ÜBAG MVZ Mitte / MVZ Delitzsch GmbH | Withdrawn | Leipzig | 04103 | Germany |
| Praxis Hämatologie und Onkologie Magdeburg | Withdrawn | Magdeburg | 39104 | Germany |
| Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie | Withdrawn | Magdeburg | 39120 | Germany |
| Klinikum rechts der Isar der Technischen Universität München | Active, not recruiting | München | 81675 | Germany |
| Pi.Tri-Studien GmbH | Withdrawn | Offenburg | 77654 | Germany |
| Klinikum am Steinenberg Reutlingen | Active, not recruiting | Reutlingen | 72764 | Germany |
| Nädler GmbH | Withdrawn | Rinteln | 31737 | Germany |
| CaritasKlinikum Saarbrücken | Active, not recruiting | Saarbrücken | 66113 | Germany |
| Praxis Onkologie Rheinsieg | Active, not recruiting | Troisdorf | 53840 | Germany |
| Universitätsklinikum Würzburg (UKW) | Withdrawn | Würzburg | 97080 | Germany |
| AOU delle Marche | Withdrawn | Ancona Torrette | 60126 | Italy |
| ASL AT - Presidio Ospedaliero "Cardinal Massaia" | Withdrawn | Asti | 14100 | Italy |
| IRCCS "S. De Bellis" | Recruiting | Castellana Grotte | 70013 | Italy |
|
| ARNAS Garibaldi - PO Nesima | Recruiting | Catania | 95122 | Italy |
|
| AOU Careggi | Recruiting | Florence | 50134 | Italy |
|
| IRCCS AOU San Martino | Recruiting | Genova | 16132 | Italy |
|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
|
| Azienda Ospedaliero-Universitaria di Modena | Recruiting | Modena | 41124 | Italy |
|
| A.O.U. Cagliari - Policlinico Universitario Duilio Casula | Withdrawn | Monserrato | 09042 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Recruiting | Naples | 80131 | Italy |
|
| Università degli studi di Napoli Federico II | Recruiting | Naples | 80131 | Italy |
|
| Università della Campania 'Luigi Vanvitelli' | Recruiting | Naples | 80131 | Italy |
|
| AOU Pisana - Stabilimento Santa Chiara | Recruiting | Pisa | 56126 | Italy |
|
| Azienda Sanitaria Locale di Biella - Ospedale degli Infermi | Withdrawn | Ponderano | 13875 | Italy |
| AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna | Recruiting | Ravenna | 48121 | Italy |
|
| Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | 00128 | Italy |
|
| AO San Camillo Forlanini | Withdrawn | Roma | 00182 | Italy |
| AO San Giovanni Addolorata | Withdrawn | Roma | 00184 | Italy |
| IRCCS Ospedale Casa Sollievo della Sofferenza | Withdrawn | San Giovanni Rotondo | 71013 | Italy |
| AO "Cardinale Giovanni Panico" | Recruiting | Tricase | 73039 | Italy |
|
| ASU FC - Ospedale "Santa Maria della Misericordia" | Withdrawn | Udine | 33100 | Italy |
| Azienda ULSS 8 Berica - Ospedale San Bortolo | Withdrawn | Vicenza | 36100 | Italy |
| ULS Almada-Seixal | Withdrawn | Almada | 2805-267 | Portugal |
| USL Braga | Withdrawn | Braga | 4710-243 | Portugal |
| ULS Coimbra | Withdrawn | Coimbra | 3004-561 | Portugal |
| IPO Lisboa | Withdrawn | Lisbon | 1099-023 | Portugal |
| CC Champalimaud | Withdrawn | Lisbon | 1400-038 | Portugal |
| Hospital da Luz | Withdrawn | Lisbon | 1500-650 | Portugal |
| ULS Santo António | Withdrawn | Porto | 4050-342 | Portugal |
| Vila Real | Withdrawn | Vila Real | 5000-508 | Portugal |
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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