Меню
Набор скоро начнётся NCT07593196

HER2-positive Metastatic Breast Cancer in Kazakhstan

— Наблюдательное Metastatic Breast Cancer

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Metastatic Breast Cancer. Базовые параметры: 18 лет — 99 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
Казахстан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Kazakhstan Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Обзор

Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period). Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.

Первичные конечные точки

  • (1) To assess median PFS and PFS rate in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan [Срок оценки: up to 2 years]
Вторичные конечные точки (6)
  • To describe the clinical and demographic characteristics of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan [Срок оценки: up to 2 years]
  • (2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan [Срок оценки: up to 2 years]
  • (3) To describe the treatment approach in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan [Срок оценки: up to 2 years]
  • (4) To assess the efficacy of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan [Срок оценки: up to 2 years]
  • (5) To describe the reasons for anticancer therapy discontinuation in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan [Срок оценки: up to 2 years]
  • (6) To assess the number of therapy lines of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

  • Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion
  • The diagnosis of mBC was established between the 1st January 2022 to 31st December 2023
  • Patients with the availability of at least 24 months of follow-up data (from the date of mBC diagnosis) in the medical records at the participating site, unless patient died/moved or refused the therapy within the first 24 months of diagnosis
  • Age ≥18 years at the time of inclusion

Критерии исключения

  • Presence of other malignancies within the period from mBC diagnosis until the timepoint of data collection
  • Patients received trastuzumab deruxtecan
  • The participation in any interventional trial within period since diagnosis until the end of study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Казахстан · 12 центров
  • 'Regional Cancer Centre' Uralsk — Oral
  • Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe — Aktobe
  • 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)' — Almaty
  • Almaty Cancer Centre — Almaty
  • 'Multidisciplinary Medical Centre' of the Astana City Administration — Astana
  • National Cancer Research Centre, Astana — Astana
  • 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department — Karaganda
  • 'General Regional Hospital' of the municipal state institution 'Health Department of the A — Petropavl
  • … и ещё 4 центра

Идентификаторы

NCT: NCT07593196 · D133FR00252

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗