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)

ConditionsHER2-positive Advanced Gastric Cancer HER2-positive Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

257 Participants

are divided into 1 treatment group

Group A: Trastuzumab deruxtecan (T-DXd)1 intervention

Trial outcomes

Primary outcomes

Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Time frame