PROSPERITY - A Prospective Non-interventional Study (NIS) of Trastuzumab DeRuxtecan (T-DXd) for Adult Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction (GEJ) AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen, Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies in a Real-world Setting in Europe
Studio Clinico
Patologia: Neoplasie dello stomaco, Tumori dell’esofago
Osservazionale-Sperimentale: Osservazionale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: Non applicabile
Linee di trattamento: Non applicabile
Criteri di inclusione:
- 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.
Criteri di esclusione:
- 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.
Trattamento sperimentale:
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.
Trattamento di controllo:
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Centri partecipanti
Nord Italia
OSPEDALE CARDINAL MASSAIA
Corso Dante 202 - 14100 Asti - AT
A.O. Ospedale degli Infermi
Via dei Ponderanesi 2 - 13875 Ponderano - BI
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
Ospedale S. Maria delle Croci, Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Centro Italia
Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
Azienda Ospedaliera Universitaria delle Marche - sede di Torrette
AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
Azienda Ospedaliera San Camillo Forlanini
Via Circonvallazione Gianicolense 87 - 00152 Roma - RM
UOC Oncologia Medica
Riferimento: Dr. Carlo Garufi
Telefono: 0658704846
Email: cgarufi@scamilloforlanini.rm.it
Sud Italia e isole
IRCCS - 'Saverio de Bellis'
Via Turi 27 - 70013 Castellana Grotte - BA
IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG
Ospedale 'Card. G. Panico'
Via San Pio X 4 - 73039 Tricase - LE
AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA
Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini 5 - 80131 Napoli - NA
Informazioni Generali
Protocollo
Numero di iscrizione a registro: NCT05993234
Data di inserimento: 18.11.2025
Promotore
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Principal Investigator ITALIA
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na