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 (RosaLEE)
Observational
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2022
juin 2028
25 juin 2024
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 | 14/05/2024 09:10:27 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:54 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 16/04/2024 07:02:15 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:37 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Sakina SEKKATE | 21/10/2024 07:07:27 | Contacter | ||
| 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 Cedex 2 - Alpes Maritimes - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 06414 - Cannes - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 11000 - Carcassonne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13885 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 13915 - Marseille cedex 20 - Bouches Du Rhone - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 16800 - Soyaux - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 25030 - Besancon Cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 26000 - Valence - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 30029 - Nimes Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 31076 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 34500 - Beziers - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 34535 - Beziers - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 35403 - ST Malo Cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 37170 - Chambray Les Tours - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 38028 - Grenoble - Isere - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 42030 - St Etienne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 42100 - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 44600 - Saint Nazaire - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 49325 - Cholet - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 50102 - Cherbourg - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 51050 - Reims - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 51056 - Reims - Marne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 52100 - Saint Dizier - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 54000 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 54519 - Vandoeuvre-les-Nancy - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57070 - Metz - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57070 - Vantoux - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57085 - Metz - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 57100 - Thionville - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59187 - Dechy - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59240 - Dunkerque - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 60200 - Compiegne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 60321 - Compiegne cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 63011 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 63050 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 66000 - Perpignan - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 67085 - Strasbourg cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 68024 - Colmar Cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69100 - Villeurbanne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69400 - Gleize - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69495 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 71230 - St Vallier - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 71321 - Chalon sur Saone - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 74370 - Metz Tessy - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75475 - Paris 10 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75970 - Paris - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 76038 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 76100 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 79021 - Niort - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 83056 - Toulon La Seyne Sur Mer - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 83608 - Frejus - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 83800 - Toulon Cedex 9 - Val De Marne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 84082 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 85925 - La Roche sur Yon Cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 91100 - Corbeil Essonnes - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 92200 - Neuilly-sur-seine - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 92210 - Saint-Cloud - Hauts De Seine - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94000 - Creteil - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94507 - Champigny Sur Marne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95107 - Argenteuil - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95200 - Sarcelles - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 95600 - Eaubonne - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 97410 - La Reunion - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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.
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.
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.