Trial Title:
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
NCT ID:
NCT05697146
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR+/HER2- advanced or metastatic breast cancer
RosaLEE
NIS
France
Ribociclib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
ribociclib + ET
Description:
There is no treatment allocation. Patients administered ribociclib + endocrine Therapy
(ET) by prescription will be enrolled.
Arm group label:
ribociclib + ET
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Advanced HR+/HER2- breast cancer population treated with ribociclib in France
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Pre-/perimenopausal and postmenopausal women with HR+/HER2- advanced or metastatic breast
cancer
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nice Cedex 2
Zip:
06189
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Marseille cedex 20
Zip:
13915
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Grenoble
Zip:
38028
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Reims
Zip:
51056
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toulon Cedex 9
Zip:
83800
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Argenteuil
Zip:
95107
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Avignon
Zip:
84082
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Bayonne
Zip:
64100
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Besancon Cedex
Zip:
25030
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Beziers
Zip:
34500
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Beziers
Zip:
34535
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Cannes
Zip:
06414
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Carcassonne
Zip:
11000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chalon sur Saone
Zip:
71321
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chambray Les Tours
Zip:
37170
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chambray Les Tours
Zip:
37170
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Champigny Sur Marne
Zip:
94507
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Cherbourg
Zip:
50102
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Cholet
Zip:
49325
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Clermont Ferrand
Zip:
63011
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Clermont Ferrand
Zip:
63050
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Colmar Cedex
Zip:
68024
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Compiegne cedex
Zip:
60321
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Compiegne
Zip:
60200
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Corbeil Essonnes
Zip:
91100
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Creteil
Zip:
94000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Dechy
Zip:
59187
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Dunkerque
Zip:
59240
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Eaubonne
Zip:
95600
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Frejus
Zip:
83608
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Gleize
Zip:
69400
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
La Reunion
Zip:
97410
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
La Roche sur Yon Cedex
Zip:
85925
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Marseille
Zip:
13008
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Marseille
Zip:
13885
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Metz Tessy
Zip:
74370
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Metz
Zip:
57070
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Metz
Zip:
57085
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Montpellier
Zip:
34070
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nancy
Zip:
54000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Neuilly-sur-seine
Zip:
92200
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nimes Cedex 9
Zip:
30029
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Niort
Zip:
79021
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Paris 10
Zip:
75475
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Paris
Zip:
75970
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Perpignan
Zip:
66000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Pierre Benite
Zip:
69495
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Reims
Zip:
51050
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Rouen
Zip:
76038
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Rouen
Zip:
76100
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Saint Dizier
Zip:
52100
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Saint Etienne
Zip:
42100
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Saint Nazaire
Zip:
44600
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sarcelles
Zip:
95200
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Soyaux
Zip:
16800
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
St Etienne
Zip:
42030
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
ST Malo Cedex
Zip:
35403
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
St Vallier
Zip:
71230
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Strasbourg cedex
Zip:
67085
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Thionville
Zip:
57100
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toulon La Seyne Sur Mer
Zip:
83056
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toulouse
Zip:
31076
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Valence
Zip:
26000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Valenciennes
Zip:
59300
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Vandoeuvre-les-Nancy
Zip:
54519
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Vantoux
Zip:
57070
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Villeurbanne
Zip:
69100
Country:
France
Status:
Active, not recruiting
Start date:
December 13, 2022
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05697146
