Biomarker-directed treatment for advanced breast cancer
Trans-RosaLEE Study: a Biomarker-directed, Translational Study of High-throughput Molecular Profiling of HR+/HER2- Metastatic Breast Cancer Treated With Endocrine Therapy and Ribociclib.
This study is testing if a targeted therapy combined with hormone treatment can help people with advanced breast cancer by looking at their tumor markers to see who might benefit the most.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 241 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05529862 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with hormone receptor-positive and HER2-negative metastatic breast cancer, aiming to improve treatment outcomes by utilizing biomarker analysis. It involves pre- and post-treatment biopsies and blood sampling to assess the effectiveness of ribociclib, a targeted therapy, in combination with endocrine therapy. The goal is to identify which patients are likely to benefit from this treatment and to understand the mechanisms behind treatment resistance. By analyzing tumor samples, the study seeks to personalize treatment approaches for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients enrolled in the RosaLEE study with available tumor samples for analysis.
Not a fit: Patients with brain metastases or non-osteolytic bone metastases as their only metastatic sites may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment strategies for patients with advanced breast cancer.
How similar studies have performed: Other studies have shown promise in using biomarker-directed therapies for breast cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille
- Institut Paoli Calmettes — Marseille, France (Recruiting)
Study contacts
- Principal investigator: François Bertucci, MD PhD — Institut Paoli-Calmettes
- Study coordinator: Dominique Genre
- Email: drci.up@ipc.unicancer.fr
- Phone: 0491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.