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Active, not recruiting Observational

Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France

NCT05697146 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-12-13
Last updated
2026-03-16

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

ribociclib + ET

ribociclib + ET: There is no treatment allocation. Patients administered ribociclib + endocrine Therapy (ET) by prescription will be enrolled.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of patients by initial dose of ribociclib — Baseline
    Proportion of patients by initial dose of ribociclib to be collected
  • Proportion of patients by endocrine therapy partner — Baseline, up to 54 months
    Proportion of patients by endocrine therapy partner to be collected(e.g., tamoxifen, letrozole, fulvestrant, anastrozole, exemestane, LHRH agonist)
  • Proportion of patients for each line of treatment with ribociclib — Baseline
    Proportion of patients for each line of treatment with ribociclib (1L, 2L, \>2L) to be collected

Trial sites (82)

FacilityCityRegionStatus
Novartis Investigative Site Nice Alpes Maritimes
Novartis Investigative Site Marseille Bouches Du Rhone
Novartis Investigative Site Dijon Cote D Or
Novartis Investigative Site Saint-Denis France
Novartis Investigative Site Valenciennes France
Novartis Investigative Site Saint-Cloud Hauts De Seine
Novartis Investigative Site Grenoble Isere
Novartis Investigative Site Reims Marne
Novartis Investigative Site Toulon Val De Marne
Novartis Investigative Site Amiens France
Novartis Investigative Site Argenteuil France
Novartis Investigative Site Avignon France
Novartis Investigative Site Bayonne France
Novartis Investigative Site Besançon France
Novartis Investigative Site Béziers France
Novartis Investigative Site Béziers France
Novartis Investigative Site Brive-la-Gaillarde France
Novartis Investigative Site Cannes France
Novartis Investigative Site Carcassonne France
Novartis Investigative Site Chalon-sur-Saône France
Novartis Investigative Site Chambray-lès-Tours France
Novartis Investigative Site Champigny-sur-Marne France
Novartis Investigative Site Cherbourg France
Novartis Investigative Site Cholet France
Novartis Investigative Site Clermont-Ferrand France
Novartis Investigative Site Clermont-Ferrand France
Novartis Investigative Site Colmar France
Novartis Investigative Site Compiègne France
Novartis Investigative Site Compiègne France
Novartis Investigative Site Corbeil-Essonnes France
Novartis Investigative Site Créteil France
Novartis Investigative Site Dechy France
Novartis Investigative Site Dijon France
Novartis Investigative Site Dunkirk France
Novartis Investigative Site Eaubonne France
Novartis Investigative Site Fréjus France
Novartis Investigative Site Gleizé France
Novartis Investigative Site La Roche-sur-Yon France
Novartis Investigative Site Libourne France
Novartis Investigative Site Lyon France

+ 42 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05697146 on ClinicalTrials.gov ↗ ← All trials in France