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

NCT06459791 | Recruiting

• 1 other identifier: IC 2023-08
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

tumorogram; metastatic breast cancer; avatar; Organoid; PDO

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• Comparison of response rate between both the arms

  6 months

• Organoid cultures achievement

  6 months

• Tumorograms performance

  6 months

• Overall survival

  up to 18 months

Study Arms (2)

Line N in step 1

OTHER

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

Procedure: Biopsy

Line N+1 in step 2

EXPERIMENTAL

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.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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

Also known as: Line N+1 treatment recommandation

Line N in step 1; Line N+1 in step 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (3)

Institut Curie

Paris, 75005, France

RECRUITING

Hôpital Saint-Louis - AP-HP Senopole

Paris, 75010, France

NOT YET RECRUITING

Institut Curie

Saint-Cloud, 92210, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Luc CABEL, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luc CABEL, MD

CONTACT

+33 1 56 24 55 00; drci.promotion@curie.fr

Anne-Sophie Plissonnier

CONTACT

+33 1 47 11 23 78; anne-sophie.plissonnier@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Methodology: RIPH 1, Phase II, multi-center, single-arm, non-randomized study

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 14, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (3)