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)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Trastuzumab deruxtecan.
- Кому может быть актуально
- Состояния в реестре: HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия, Бельгия, Германия, Италия, Португалия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Trastuzumab 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.
Первичные конечные точки
- Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [Срок оценки: Baseline up to approximately 2 years]
Вторичные конечные точки (6)
- Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline up to approximately 2 years]
- Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline up to approximately 2 years]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 25 центров
- MVZ am Klinikum Aschaffenburg — Aschaffenburg
- Universitätsklinikum Augsburg — Augsburg
- Vivantes Klinikum im Friedrichshain — Berlin
- Charite Campus Benjamin Franklin — Berlin
- Klinikum Chemnitz gGmbH — Chemnitz
- MV-Zentrum für Hämatologie & Onkologie — Cologne
- Universitätsklinikum Düsseldorf — Düsseldorf
- University Hospital Essen — Essen
- … и ещё 17 центров
Италия · 23 центра
- AOU delle Marche — Ancona Torrette
- ASL AT - Presidio Ospedaliero "Cardinal Massaia" — Asti
- IRCCS "S. De Bellis" — Castellana Grotte
- ARNAS Garibaldi - PO Nesima — Catania
- AOU Careggi — Florence
- IRCCS AOU San Martino — Genova
- IRCCS Ospedale San Raffaele — Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- … и ещё 15 центров
Бельгия · 11 центров
- OLV Hospital Aalst — Aalst
- Imelda vzw — Bonheiden
- HUB institut Jules Bordet — Brussels
- Grand hôpital de Charleroi — Charleroi
- Antwerp University Hospital — Edegem
- UZ Gent — Ghent
- CHU Helora Hospital de La Louvière - Site Jolimont — Haine-Saint-Paul
- JESSA Hasselt — Hasselt
- … и ещё 3 центра
Австрия · 9 центров
- KABEG Klinikum Klagenfurt am Wörthersee - Landeskrankenanstalten LKH — Klagenfurt
- Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz
- Universitätsklinikum St. Pölten - Lilienfeld — Sankt Pölten
- Medizinische Universität Wien — Vienna
- St. Josef Krankenhaus GmbH Ein Unternehmen der Vinzenz Gruppe — Vienna
- Klinik Ottakring, Wilhelminenspital der Stadt Wien — Vienna
- Kepler Universitätsklinikum — Wels
- Landesklinikum Wiener Neustadt — Wiener Neustadt
- … и ещё 1 центр
Португалия · 8 центров
- ULS Almada-Seixal — Almada
- USL Braga — Braga
- ULS Coimbra — Coimbra
- IPO Lisboa — Lisbon
- CC Champalimaud — Lisbon
- Hospital da Luz — Lisbon
- ULS Santo António — Porto
- Vila Real — Vila Real
Идентификаторы
NCT: NCT05993234 · DS8201-0007-NIS-MA