Clinical trial · Observational
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France: a National, Multicenter, Prospective, Non-interventional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine therapy (ET) treatment according to the marketing authorization has been taken and was taken independent and prior to study participation decision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ribociclib + ET | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ribociclib + ET
- description
- Women prescribed ribociclib + Endocrine Therapy (ET)
- interventionNames
- Other: ribociclib + ET
Primary outcomes (3)
- measure
- Proportion of patients by initial dose of ribociclib
- timeFrame
- Baseline
- description
- Proportion of patients by initial dose of ribociclib to be collected
- measure
- Proportion of patients by endocrine therapy partner
- timeFrame
- Baseline, up to 54 months
- description
- Proportion of patients by endocrine therapy partner to be collected(e.g., tamoxifen, letrozole, fulvestrant, anastrozole, exemestane, LHRH agonist)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Patients who meet all of the following criteria will be included in the RosaLEE study: 1. Adult women aged ≥ 18 years old at inclusion. 2. Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC. 3. Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization. 4. Patients having given their non-objection to participate in the study. 5. Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics. Exclusion Criteria: 1. Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion. 2. Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion. 3. Patients for whom AI or fulvestrant in monotherapy has been initiated \> 28 days before inclusion. 4. Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC. 5. Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.
References
Publications (0)
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