About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
More than 3 lines of chemotherapy in the advanced setting (excluding hormone therapy/CDK4/6 inhibitor)
Progressive brain metastases
Leptomeningeal metastasis
Trial design
Parallel
Treatments tested in this trial
Biopsy
Procedure/SurgeryThe recommandation done based on informative tumorogram is up to study investigator
Treatment groups
Trial outcomes
Primary outcomes
Tumor 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.
Secondary outcomes
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;
Organoid cultures achievement
Percentage of achievement of a PDO
Tumorograms performance
Percentage of informative tumorograms versus number of tumorograms returned
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.
Sponsors and contacts
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