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Идёт набор NCT06459791

Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Organoid (AVATAR)

Без фазы С лечением 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
В протоколе указаны: Biopsy.
Кому может быть актуально
Состояния в реестре: Metastatic Breast Cancer. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar: Proof-of-concept Study

Обзор

A biopsy of a tumor lesion (breast or other localisation) will be performed for processing to establish avatars (patient-derived organoids -PDO). A personalized tumorogram for each patient will be provided, based on the results of the drug screening (= tumor predicted as sensitive, intermediate, resistant or non-evaluable for each drug tested). Patients with an informative tumorogram will receive one of the recommended treatments (line N+1) in the event of tumor progression, administered according to standard procedures and validated at medical meetings specific to each center, and their fate will be monitored.

Подробное описание

A biopsy of a tumor lesion (breast or other localisation) will be performed and transferred to the LIP laboratory at the Institut Curie (Laboratoire d'Investigation Préclinique, Département de Recherche Translationnelle) for processing to establish avatars (patient-derived organoids -PDO).

Step 1: Establishment of avatar (PDO): follow-up of line N (standard care) when the tumorogram is established, then follow-up of standard line N+1.

* The patient will then be treated (line N) as part of standard care while awaiting the result of the tumorogram. * A drug screening will be carried out on the PDO (\~5-10 drugs/patient), which will be progressive and adapted to the clinical context (including treatment history), including drugs used in standard care (cf. list in Table 1). * A personalized tumorogram for each patient will be provided, based on the results of the drug screening (= tumor predicted as sensitive, intermediate, resistant or non-evaluable for each drug tested). * A multidisciplinary committee will be set up for this study, which will meet regularly (\~1 time per week) to discuss patients included in the study, obtaining PDOs, drugs to be prioritized in the screening, results of the drug screening and personalized tumorograms. The committee will include at least one oncologist and one biologist from the laboratory. * The multidisciplinary committee will make a therapeutic recommendation based on the personalized tumorogram, which may include several drugs considered sensitive to the tumour * A tumorogram will be considered as informative if it proposes at least one chemotherapy molecule considered as sensitive in the PDO model. * Patients whose PDO could not be obtained, or whose tumorogram was not informative, will receive standard treatment.

Step 2: informative tumorogram: follow-up of experimental line N+1 Patients with an informative tumorogram will receive one of the recommended treatments (line N+1) in the event of tumor progression, administered according to standard procedures and validated at medical meetings specific to each center, and their fate will be monitored.

Вмешательства

  • Процедура Biopsy
    The recommandation done based on informative tumorogram is up to study investigator

Первичные конечные точки

  • Tumor response rate [Срок оценки: 6 months]
Вторичные конечные точки (4)
  • Comparison of response rate between both the arms [Срок оценки: 6 months]
  • Organoid cultures achievement [Срок оценки: 6 months]
  • Tumorograms performance [Срок оценки: 6 months]
  • Overall survival [Срок оценки: up to 18 months]

Критерии участия

Критерии включения

  • Patient over 18 years of age
  • Advanced breast cancer
  • Triple-negative phenotype (HR-/HER2-) or HR+/HER2- after hormone resistance (progression after treatment with hormone therapy + CDK4/6 inhibitor)
  • Tumor measurable according to RECISTv1.1 criteria, accessible to biopsy
  • Performans Status 0-1

Критерии исключения

  • More than 3 lines of chemotherapy in the advanced setting (excluding hormone therapy/CDK4/6 inhibitor)
  • Progressive brain metastases
  • Leptomeningeal metastasis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 3 центра
  • Institut Curie — Paris
  • Hôpital Saint-Louis - AP-HP Senopole — Paris
  • Institut Curie — Saint-Cloud

Идентификаторы

NCT: NCT06459791 · IC 2023-08

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗