Last Update: Jan 16, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLEE011AFR01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Included patients will be followed until the end of study, death or lost to follow-up even if ribociclib and ET are discontinued. The end of the study is defined as 3 years after the first visit of the last patient included (Last Patient First Visit [LPFV]). The total duration of the study will be 4 years and half (18 months of inclusion + 3 years of follow-up). Thus, a patient included at the beginning of the inclusion period will be followed for 4 years and half and a patient included at the end of the inclusion period will be followed for at least 3 years.

Breast Cancer
Recruiting
482
Dec 13, 2022
Jun 28, 2027
Female
18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

ribociclib + ET

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

Eligibility Criteria

Inclusion Criteria:

Patients who meet all of the following criteria will be included in the RosaLEE study:

Adult women aged ≥ 18 years old at inclusion.
Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC.
Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization.
Patients having given their non-objection to participate in the study.
Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics.

Exclusion Criteria:

Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion.
Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion.
Patients for whom AI or fulvestrant in monotherapy has been initiated > 28 days before inclusion.
Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC.
Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.

Study Location

Novartis Investigative Site

Recruiting

Compiegne cedex,60321,France

Novartis Investigative Site

Recruiting

Saint Dizier,52100,France

Novartis Investigative Site

Recruiting

Lyon,69373,France

Novartis Investigative Site

Recruiting

Chambray Les Tours,37170,France

Novartis Investigative Site

Recruiting

Villeurbanne,69100,France

Novartis Investigative Site

Recruiting

Perpignan,66000,France

Novartis Investigative Site

Recruiting

Eaubonne,95600,France

Novartis Investigative Site

Recruiting

St Vallier,71230,France

Novartis Investigative Site

Recruiting

Montpellier,34070,France

Novartis Investigative Site

Recruiting

Bayonne,64100,France

Novartis Investigative Site

Recruiting

Toulon La Seyne Sur Mer,83056,France

Novartis Investigative Site

Recruiting

Compiegne,60200,France

Novartis Investigative Site

Recruiting

Saint Etienne,42100,France

Novartis Investigative Site

Recruiting

Marseille Cedex 05,13885,France

Novartis Investigative Site

Recruiting

Pierre Benite,69495,France

Novartis Investigative Site

Recruiting

Champigny Sur Marne,94507,France

Novartis Investigative Site

Recruiting

Frejus,83608,France

Novartis Investigative Site

Recruiting

Strasbourg cedex,67085,France

Novartis Investigative Site

Recruiting

Nancy,54000,France

Novartis Investigative Site

Recruiting

Beziers,34500,France

Novartis Investigative Site

Recruiting

Toulouse Cedex 3,31076,France

Novartis Investigative Site

Recruiting

Saint Nazaire,44600,France

Novartis Investigative Site

Recruiting

Corbeil Essonnes,91100,France

Novartis Investigative Site

Recruiting

Marseille,13008,France

Novartis Investigative Site

Recruiting

Reims,51050,France

Novartis Investigative Site

Recruiting

Cherbourg,50102,France

Novartis Investigative Site

Recruiting

Thionville,57100,France

Novartis Investigative Site

Recruiting

Gleize,69400,France

Novartis Investigative Site

Recruiting

Neuilly-sur-seine,92200,France

Novartis Investigative Site

Recruiting

Beziers,34535,France

Novartis Investigative Site

Recruiting

Valence,26000,France

Novartis Investigative Site

Recruiting

Saint-Cloud,Hauts De Seine,92210,France

Novartis Investigative Site

Recruiting

Creteil,94000,France

Novartis Investigative Site

Recruiting

Marseille,13273,France

Novartis Investigative Site

Recruiting

Reims,Marne,51056,France

Novartis Investigative Site

Recruiting

Cholet,49325,France

Novartis Investigative Site

Recruiting

Toulon Cedex 9,Val De Marne,83800,France

Novartis Investigative Site

Recruiting

Grenoble Cedex 1,Isere,38028,France

Novartis Investigative Site

Recruiting

Cannes,06414,France

Novartis Investigative Site

Recruiting

Valenciennes,59300,France

Novartis Investigative Site

Recruiting

Nice Cedex 2,Alpes Maritimes,06189,France

Novartis Investigative Site

Recruiting

Soyaux,16800,France

Novartis Investigative Site

Recruiting

Dechy,59187,France

Novartis Investigative Site

Recruiting

Metz Tessy,74370,France

Novartis Investigative Site

Recruiting

Rouen,76038,France

Novartis Investigative Site

Recruiting

Clermont Ferrand,63050,France

Novartis Investigative Site

Recruiting

La Reunion,97410,France

Novartis Investigative Site

Recruiting

Carcassonne,11000,France

Novartis Investigative Site

Recruiting

Vandoeuvre-les-Nancy,54519,France

Novartis Investigative Site

Recruiting

Nimes Cedex 9,30029,France

Novartis Investigative Site

Recruiting

St Etienne,42030,France

Novartis Investigative Site

Recruiting

Dijon,21000,France

Novartis Investigative Site

Recruiting

Argenteuil,95107,France

Novartis Investigative Site

Recruiting

Metz,57070,France

Novartis Investigative Site

Recruiting

Colmar Cedex,68024,France

Novartis Investigative Site

Recruiting

Rouen,76100,France

Novartis Investigative Site

Recruiting

La Roche sur Yon Cedex,85925,France

Novartis Investigative Site

Recruiting

Chalon sur Saône,71321,France

Novartis Investigative Site

Recruiting

Villejuif,94800,France

Novartis Investigative Site

Recruiting

Niort,79021,France

Novartis Investigative Site

Recruiting

Dunkerque,59240,France

Novartis Investigative Site

Recruiting

ST Malo Cedex,35403,France

Novartis Investigative Site

Recruiting

Avignon,84082,France

Novartis Investigative Site

Recruiting

Metz,57085,France

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals