Status:
RECRUITING
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)
Lead Sponsor:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
HER2-positive Advanced Gastric Cancer
HER2-positive Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
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 r...
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 intervention...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT05993234
Start Date
December 5 2023
End Date
September 1 2027
Last Update
December 11 2025
Active Locations (76)
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1
KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH
Klagenfurt, Austria, 9020
2
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria, 4010
3
Universitätsklinikum St. Pölten - Lilienfeld
Sankt Pölten, Austria, 3100
4
Medizinische Universität Wien
Vienna, Austria, 1090