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This study carries out biomarker-directed translational research using tissue and blood samples taken before and after ribociclib plus endocrine therapy in patients from the RosaLEE study. It enrolled patients who were part of the RosaLEE study and gave the required consent. It is a study without a phase; it is not currently recruiting but is still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Patients included in the RosaLEE study. 2. Patients having read and signed the ICF relative to Trans-RosaLEE. 3. Tumour material: primary and/or metastatic tumour sample, either available as frozen and collected within 3 months before V0, or newly collected before ribociclib + ET treatment initiation. Brain metastases and non-osteolytic bone metastases will be considered as non-collectable/biopsable. 4. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen. Exclusion Criteria: 1. Not enrolled in RosaLEE. 2. Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no available frozen tumour sample already collected within 3 months before V0. 3. Tumour material not collected before ribociclib + ET initiation. 4. Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to give their consent.