Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06459791 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Tumeurs du sein

Phase

N/A

Promoteur

Institut Curie (Voir sur ClinicalTrials)

Date de début

décembre 2024

Date de fin

septembre 2028

Dernière mise à jour

03 janvier 2025

Résumé

A biopsy of a breast tumor lesion 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.

Détail

Voir le détail A biopsy of a breast tumor lesion 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CLCC INSTITUT CURIE	Florence COUSSY, MD	En recrutement IDF	Contact (sur clinicalTrials)
CLCC RENE HUGUENIN INSTITUT CURIE	Alexandre DE MOURA, MD	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Saint-Louis - AP-HP Senopole - 75010 - Paris - France	Louis TEXEIRA, PhD	Recrutement non commencé	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

1. Patient over 18 years of age

2. Advanced breast cancer

3. Triple-negative phenotype (HR-/HER2-) or HR+/HER2- after hormone resistance
(progression after treatment with hormone therapy + CDK4/6 inhibitor)

4. Tumor measurable according to RECISTv1.1 criteria, accessible to biopsy

5. Performans Status 0-1

Critère de non inclusion

1. More than 3 lines of chemotherapy in the advanced setting (excluding hormone
therapy/CDK4/6 inhibitor)

2. Progressive brain metastases

3. Leptomeningeal metastasis

NCT06459791 - Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar: Proof-of-concept Study (AVATAR)

Informations générales
Etablissements
Critères
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