Metastatic Breast CancerAVATARNCT06459791
Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Organoid (AVATAR)
A study testing Biopsy in people with Metastatic Breast Cancer, run by Institut Curie at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Dec 2024to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- More than 3 lines of chemotherapy in the advanced setting (excluding hormone therapy/CDK4/6 inhibitor)
- Progressive brain metastases
- Leptomeningeal metastasis
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Institut Curie
Paris, 75005
Luc CABEL, MD
LUC CABEL, MD
- Not yet recruiting
Hôpital Saint-Louis - AP-HP Senopole
Paris, 75010
Delphine COCHEREAU, MD
Delphine COCHEREAU, MD
- Recruiting
Institut Curie
Saint-Cloud, 92210
Alexandre DE MOURA, MD
Alexandre DE MOURA, MD
About this study
Official title: Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar: Proof-of-concept Study
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.
Read the detailed description
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Biopsy
- Keywords
- tumorogram, metastatic breast cancer, avatar, Organoid, PDO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Line N+1 treatment recommandation
The recommandation done based on informative tumorogram is up to study investigator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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;
Measured: 6 months
Organoid cultures achievement
Percentage of achievement of a PDO
Measured: 6 months
Tumorograms performance
Percentage of informative tumorograms versus number of tumorograms returned
Measured: 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.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start6 Dec 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Methodology: RIPH 1, Phase II, multi-center, single-arm, non-randomized study
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc CABEL, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459791
- Sponsor's protocol ID
- IC 2023-08
- Acronym
- AVATAR
- Status last verified
- Jan 2026
- First submitted
- 27 May 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Biological Avatar: Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06459791
- Acronym / sponsor ID
- AVATAR / IC 2023-08
- Conditions
- Metastatic Breast Cancer
- Keywords
- tumorogram, metastatic breast cancer, avatar, Organoid, PDO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Methodology: RIPH 1, Phase II, multi-center, single-arm, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Line N in step 1 | Other | Procedure: BiopsyStep 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 |
| Line N+1 in step 2 | Experimental | Procedure: BiopsyStep 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- More than 3 lines of chemotherapy in the advanced setting (excluding hormone therapy/CDK4/6 inhibitor)
- Progressive brain metastases
- Leptomeningeal metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: Line N+1 treatment recommandationThe recommandation done based on informative tumorogram is up to study investigator | Procedure or surgery | Line N in step 1, Line N+1 in step 2 |
Primary outcome
Tumor response rate
Time frame: 6 months
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.
4 secondary outcomes
Comparison of response rate between both the arms
Time frame: 6 months
Organoid cultures achievement
Time frame: 6 months
Tumorograms performance
Time frame: 6 months
Overall survival
Time frame: up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luc CABEL, MD principal investigator
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Metastatic Breast Cancer, run by Institut Curie at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luc CABEL, MD (+33 1 56 24 55 00, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.