Trans-RosaLEE Study: a Biomarker-directed, Translational Study

Launched by INSTITUT PAOLI-CALMETTES · Sep 2, 2022

Keywords

ClinConnect Summary

The Trans-RosaLEE Study is researching how a new treatment called Kisqali® (ribociclib) works for women with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative. This trial aims to understand why some patients respond well to this treatment while others do not. By analyzing tumor samples and blood from patients before they start treatment and after they finish it, the study hopes to find important clues about how to better personalize therapy and identify which patients are likely to benefit from Kisqali® combined with hormone therapy.

To participate in this study, women need to be enrolled in a related study called RosaLEE and have a sample of their tumor collected within three months before starting treatment. The study will include up to 241 patients across 90 healthcare centers in France. Participants can expect to provide blood and tumor samples, and their health will be monitored throughout the study to see how their cancer responds to the treatment. This research could lead to better treatment options for future patients facing similar challenges.

Gender

FEMALE

Eligibility criteria

• 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.