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)
Recruiting now
Conditions studied: HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT05993234
- Run by
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- People needed
- 257
- Starts
- 2023-12-05
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
Where it is running
- AUSL della Romagna - Ospedale "S. Maria delle Croci" di Ravenna — Ravenna, Italy (enrolling)
- IRCCS "S. De Bellis" — Castellana Grotte, Italy (enrolling)
- Azienda Ospedaliero-Universitaria di Modena — Modena, Italy (enrolling)
- AO "Cardinale Giovanni Panico" — Tricase, Italy (enrolling)
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale — Naples, Italy (enrolling)
- ARNAS Garibaldi - PO Nesima — Catania, Italy (enrolling)
- AOU Careggi — Florence, Italy (enrolling)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (enrolling)
- Università della Campania 'Luigi Vanvitelli' — Naples, Italy (enrolling)
- Policlinico Universitario Campus Bio-Medico — Roma, Italy (enrolling)
- AOU Pisana - Stabilimento Santa Chiara — Pisa, Italy (enrolling)
- Università degli studi di Napoli Federico II — Naples, Italy (enrolling)
- IRCCS Ospedale San Raffaele — Milan, Italy (enrolling)
- IRCCS AOU San Martino — Genova, Italy (enrolling)
- UZ Gent — Ghent, Belgium
- Antwerp University Hospital — Edegem, Belgium
- Kepler Universitätsklinikum — Wels, Austria
- Grand hôpital de Charleroi — Charleroi, Belgium
- HUB institut Jules Bordet — Brussels, Belgium
- Klinik Ottakring, Wilhelminenspital der Stadt Wien — Vienna, Austria
- Universitätsklinikum St. Pölten - Lilienfeld — Sankt Pölten, Austria
- Vivantes Klinikum im Friedrichshain — Berlin, Germany
- Charite Campus Benjamin Franklin — Berlin, Germany
- Klinikum Chemnitz gGmbH — Chemnitz, Germany
- Universitätsklinikum Augsburg — Augsburg, Germany
Full record on ClinicalTrials.gov
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