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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Saint-Louis - AP-HP Senopole
NOT_YET_RECRUITING
Paris
Institut Curie
RECRUITING
Paris
Institut Curie
RECRUITING
Saint-cloud
Contact Information
Primary
Luc CABEL, MD
drci.promotion@curie.fr
+33 1 56 24 55 00
Backup
Anne-Sophie Plissonnier
anne-sophie.plissonnier@curie.fr
+33 1 47 11 23 78
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 110
Treatments
Other: Line N in step 1
Step 1: follow-up of line N (standard care) when the tumorogram is established. Intervention is the biopsy performed before start of treatment in line N. Standard of Care treatment
Experimental: Line N+1 in step 2
Step 2: in case of informative tumorogram: follow-up of experimental line N+1. If tumorogram is informative on organoid issued from biospy, a specific standard of Care treatment will be recommanded.
Related Therapeutic Areas
Sponsors
Leads: Institut Curie

This content was sourced from clinicaltrials.gov

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