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Trial Title:
Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Organoid
NCT ID:
NCT06459791
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
tumorogram
metastatic breast cancer
avatar
Organoid
PDO
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Methodology: RIPH 1, Phase II, multi-center, single-arm, non-randomized study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
The recommandation done based on informative tumorogram is up to study investigator
Arm group label:
Line N in step 1
Arm group label:
Line N+1 in step 2
Other name:
Line N+1 treatment recommandation
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Exclusion Criteria:
1. More than 3 lines of chemotherapy in the advanced setting (excluding hormone
therapy/CDK4/6 inhibitor)
2. Progressive brain metastases
3. Leptomeningeal metastasis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Contact:
Last name:
Florence COUSSY, MD
Facility:
Name:
Hôpital Saint-Louis - AP-HP Senopole
Address:
City:
Paris
Zip:
75010
Country:
France
Contact:
Last name:
Louis TEXEIRA, PhD
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Contact:
Last name:
Alexandre DE MOURA, MD
Start date:
September 15, 2024
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06459791
