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)

Daiichi Sankyo

Status: Enrolling

Conditions: HER2-positive Gastroesophageal Junction Adenocarcinoma; HER2-positive Advanced Gastric Cancer

Treatments: Drug: Trastuzumab deruxtecan

Study type: Observational

Funder types: Industry

Identifiers

NCT05993234

DS8201-0007-NIS-MA

Details and patient eligibility

About

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.

Full description

This non-interventional study will investigate the effectiveness of T-DXd, the patients demographic and clinical characteristics, treatment patterns including prophylactic medications and interventions for reduction of serious adverse events (SAEs), serious adverse drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and patient survey of T-DXd, in cases with advanced HER2-positive gastric or GEJ adenocarcinoma receiving T-DXd as second line of treatment and beyond treatment option. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No investigational drug will be administered in this study.

Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) will also be collected in a disease registry part of the study.

Enrollment: 257 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

257 participants in 1 patient group

Trastuzumab deruxtecan (T-DXd)

Description:

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.

Treatment:

Drug: Trastuzumab deruxtecan