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 (PROSPERITY)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 257
- 试验地点
- 190
- 主要终点
- Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
时间窗: Baseline up to approximately 2 years
次要结局
- 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)
- 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)
- 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)
- 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)