HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma, Trastuzumab Deruxtecan, Conventional therapy, ENHERTU®
Brief 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.
Detailed 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.
Interventions
DRUGTrastuzumab deruxtecan
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.
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Baseline up to approximately 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Baseline up to approximately 2 years | — |
| Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only) | Baseline up to approximately 2 years | — |
| Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only) | Baseline up to approximately 2 years | — |
| Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Baseline up to approximately 2 years | — |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Baseline up to approximately 2 years | The EORTC QLQ-C30 questionnaire is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach (EORTC QLQ-STO22) Score in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Baseline up to approximately 2 years | The EORTC QLQ-STO22 is a gastric cancer-specific module which has been developed to measure the quality of life in patients with gastric cancer. The gastric cancer specific questions on the EORTC QLQ-STO22 include four single-item subscales (dry mouth, body image, hair loss and problems with taste) and five multi-item subscales (dysphagia, dietary restriction, pain, upper gastroesophageal symptoms and emotional problems). The EORTC QLQ single-item and multi-item scales range in score from 0 to 100. A higher score on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient) |
Countries
Austria, Belgium, Germany, Italy
Contacts
STUDY_DIRECTORGlobal Team Leader
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Outcome results
None listed