Trans-RosaLEE Study: a Biomarker-directed, Translational Study
NCT ID: NCT05529862
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
115 participants
INTERVENTIONAL
2023-06-20
2028-11-01
Brief Summary
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But, as with any treatment, it is expected that some patients will have a good response and their disease will be stabilized or even in remission, while other patients will not benefit from treatment and will relapse. In order to make progress, it is necessary to identify pre-therapeutic markers predictive of response to this treatment and the molecular mechanisms of this resistance set up by the tumor before or under the effect of the treatment.
The Trans-RosaLEE study aims to fill this gap by providing high-throughput molecular profiling (DNA and RNA) of a collection of tumor and blood samples from patients with RH+/HER2- mBC scheduled to start treatment with Kisqali® + ET. Samples will be collected just prior to initiation of therapy (pre-therapy) and just after discontinuation of therapy in the event of disease progression (post-therapy).
The main objectives of the TransRosaLEE study are :
* to determine if Kisqali® + ET treatment causes changes in the DNA and/or RNA genes of tumor;
* to identify whether there is a molecular signature that would predict clinical outcome of patients treated with Kisqali® + ET (tumor response, survival);
* to identify alterations in tumor's genes that could be targeted by a specific treatment and that would allow, in case of progression of the disease, to set up a new adapted treatment.
The TransRosaLEE study is a collaborative study between the Paoli-Calmettes Institute (France, Marseille) and the pharmaceutical group Novartis. It will take place in up to 90 healthcare institutions in France, and 241 patients will be enrolled. It is closely linked to the non-interventional study RosaLEE promoted by Novartis.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Locally advanced or metastatic Breast Cancer Women
Study Procedures:
* Additional tumour sampling during the pre-treatment biopsy scheduled as per routine care,
* A post-treatment tumour biopsy,
* One pre-treatment and one post-treatment blood sampling.
Pre-treatment biopsy
Pre-treatment fragments will be collected during the biopsy visit organised as part of routine medical practice, prior to the start of treatment with ribociclib + ET
Post treatment biopsy
Post-treatment fragments will be collected during a biopsy visit specifically planned for Trans-RosaLEE study.
Pre treatment blood sampling
Sampling of 4 EDTA Tubes (4ml) and 2 Streck tubes (10ml)
Post treatment blood sampling
Sampling of 2 Streck tubes (10ml)
Interventions
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Pre-treatment biopsy
Pre-treatment fragments will be collected during the biopsy visit organised as part of routine medical practice, prior to the start of treatment with ribociclib + ET
Post treatment biopsy
Post-treatment fragments will be collected during a biopsy visit specifically planned for Trans-RosaLEE study.
Pre treatment blood sampling
Sampling of 4 EDTA Tubes (4ml) and 2 Streck tubes (10ml)
Post treatment blood sampling
Sampling of 2 Streck tubes (10ml)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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François Bertucci, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Institut Paoli Calmettes
Marseille, , France
Countries
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Other Identifiers
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TransRosaLEE-IPC 2021-075
Identifier Type: -
Identifier Source: org_study_id
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