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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
The recommandation done based on informative tumorogram is up to study investigator
Institut Curie
Paris, France
RECRUITINGHôpital Saint-Louis - AP-HP Senopole
Paris, France
NOT_YET_RECRUITINGInstitut Curie
Saint-Cloud, France
RECRUITINGTumor response rate
Evaluation in the cohort of patients treated according to the informative tumorogram: tumor response rate within 6 months of the start of this treatment. Tumor response is defined as partial or complete response, assessed based on radiological criteria (RECIST v1.1) or clinical criteria where applicable.
Time frame: 6 months
Comparison of response rate between both the arms
Comparison of response rate and PFSn+1 (recommended treatment) with response rate and PFSn+1 of patients who did not have an established tumorogram;
Time frame: 6 months
Organoid cultures achievement
Percentage of achievement of a PDO
Time frame: 6 months
Tumorograms performance
Percentage of informative tumorograms versus number of tumorograms returned
Time frame: 6 months
Overall survival
Comparison of overall survival (OSn+1, defined as the time between the start of treatment on line n+1 and death) between patients treated according to the tumorogram and patients without a tumorogram and treated according to the guidelines.
Time frame: up to 18 months
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