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Active Not Recruiting NCT05993234

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 Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 257
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Location: Ordensklinikum Linz GmbH Barmherzige Schwestern Linz

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05993234). StuddyBuddy aggregates publicly available trial information.