Informations générales (source: ClinicalTrials.gov)
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
Observational
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2022
juin 2028
02 janvier 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Zineb SELLAM | 28/07/2025 08:20:01 | Contacter | ||
| CLCC INSTITUT CURIE | 10/04/2025 13:12:23 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 16/04/2024 07:02:15 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:12:05 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Sakina SEKKATE | 19/01/2026 08:41:50 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 37170 - Chambray-lès-Tours 3027343 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 06189 - Nice 2990440 - Alpes Maritimes - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 06414 - Cannes 3028808 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 11000 - Carcassonne 3028641 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13008 - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13273 - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13885 - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13915 - Marseille 2995469 - Bouches Du Rhone - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 16800 - Soyaux 2973882 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 21000 - Dijon 3021372 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 21034 - Dijon 3021372 - Cote D Or - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 25030 - Besançon 3033123 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 25200 - Montbelliard - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 26000 - Valence 2971053 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 30029 - Nîmes 2990363 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 31076 - Toulouse 2972315 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 33505 - Libourne 2998517 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 34070 - Montpellier 2992166 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 34500 - Béziers 3032833 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 34535 - Béziers 3032833 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 35403 - St-Malo 2978640 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 35404 - St-Malo 2978640 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 38028 - Grenoble 3014728 - Isere - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 42030 - Saint-Etienne 2980291 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 42100 - Saint-Etienne 2980291 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 44600 - Saint-Nazaire 2977921 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 49325 - Cholet 3025053 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 50102 - Cherbourg 3025466 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 51050 - Reims 2984114 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 51056 - Reims 2984114 - Marne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 52100 - Saint-Dizier 2980816 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 54000 - Nancy 2990999 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 54519 - Vandœuvre-lès-Nancy 2970797 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57070 - Metz 2994160 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57070 - Vantoux 2970764 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57085 - Metz 2994160 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57100 - Thionville 2972811 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59187 - Dechy 3021663 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59240 - Dunkirk 3020686 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59300 - Valenciennes 2971041 - France - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 60200 - Compiègne 3024066 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 60321 - Compiègne 3024066 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 63011 - Clermont-Ferrand 3024635 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 63050 - Clermont-Ferrand 3024635 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 66000 - Perpignan 2987914 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 68024 - Colmar 3024297 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69100 - Villeurbanne 2968254 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69337 - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69400 - Gleizé 3015823 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69495 - Pierre-Bénite 2987314 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 71230 - Saint-Vallier 2976697 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 71321 - Chalon-sur-Saône 3027484 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 74374 - Metz-Tessy 2994150 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75015 - Paris 2988507 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75475 - Paris 2988507 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75970 - Paris 2988507 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 76038 - Rouen 2982652 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 76100 - Rouen 2982652 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 79021 - Niort 2990355 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 80000 - Amiens 3037854 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 83056 - Toulon La Seyne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 83608 - Fréjus 3017253 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 83800 - Toulon 2972328 - Val De Marne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 84082 - Avignon 3035681 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 85925 - La Roche-sur-Yon 3006767 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 86021 - Poitiers 2986495 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 91100 - Corbeil-Essonnes 3023763 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 92150 - Suresnes 2973675 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 92200 - Neuilly-sur-Seine 2990611 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 92210 - Saint-Cloud 2981041 - Hauts De Seine - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94000 - Créteil 3022530 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94507 - Champigny-sur-Marne 3027105 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94800 - Villejuif 2968705 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95107 - Argenteuil 3037044 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95200 - Sarcelles 2976043 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95520 - Osny 2989130 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95600 - Eaubonne 3020601 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 97410 - Saint-Pierre 11919821 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 97490 - Saint-Denis 2980916 - France - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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.