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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Line N in step 1Other 1 intervention
Group B: Line N+1 in step 2Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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;

Time frame
6 months
2

Organoid cultures achievement

Percentage of achievement of a PDO

Time frame
6 months
3

Tumorograms performance

Percentage of informative tumorograms versus number of tumorograms returned

Time frame
6 months
4

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.

Time frame
up to 18 months

Other outcomes

Sponsors and contacts

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