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

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

ribociclib + ET

Clinical Study ID

NCT05697146
CLEE011AFR01
  • Ages 18-99
  • Female

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 Criteria

Inclusion

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 + ETaccording to the summary of product characteristics.

Exclusion

Exclusion Criteria:

  1. Patients for whom ribociclib + AI in treatment combination has been initiated beforeinclusion.

  2. Patients for whom ribociclib + fulvestrant in treatment combination has beeninitiated before inclusion.

  3. Patients for whom AI or fulvestrant in monotherapy has been initiated > 28 daysbefore inclusion.

  4. Participation in any clinical study involving investigational therapy except for theTrans-RosaLEE study, conducted by the IPC.

  5. Patient who is pregnant or has expressed desire for pregnancy during Ribociclibtreatment.

Study Design

Total Participants: 482
Treatment Group(s): 1
Primary Treatment: ribociclib + ET
Phase:
Study Start date:
December 13, 2022
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Nice, Alpes Maritimes 06189
    France

    Site Not Available

  • Novartis Investigative Site

    Nice Cedex 2, Alpes Maritimes 06189
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille cedex 20, Bouches Du Rhone 13915
    France

    Active - Recruiting

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine 92210
    France

    Site Not Available

  • Novartis Investigative Site

    Grenoble, Isere 38028
    France

    Site Not Available

  • Novartis Investigative Site

    Grenoble Cedex 1, Isere 38028
    France

    Site Not Available

  • Novartis Investigative Site

    Reims Cedex, Marne 51056
    France

    Site Not Available

  • Novartis Investigative Site

    Toulon Cedex 9, Val De Marne 83800
    France

    Site Not Available

  • Novartis Investigative Site

    Amiens, 80000
    France

    Active - Recruiting

  • Novartis Investigative Site

    Argenteuil, 95107
    France

    Site Not Available

  • Novartis Investigative Site

    Avignon, 84082
    France

    Site Not Available

  • Novartis Investigative Site

    Bayonne, 64100
    France

    Site Not Available

  • Novartis Investigative Site

    Besancon Cedex, 25030
    France

    Active - Recruiting

  • Novartis Investigative Site

    Beziers, 34500
    France

    Site Not Available

  • Novartis Investigative Site

    Bobigny Cedex, 93009
    France

    Active - Recruiting

  • Novartis Investigative Site

    Cannes, 06414
    France

    Active - Recruiting

  • Novartis Investigative Site

    Carcassonne, 11000
    France

    Site Not Available

  • Novartis Investigative Site

    Chalon sur Saone, 71321
    France

    Active - Recruiting

  • Novartis Investigative Site

    Chalon sur Saône, 71321
    France

    Site Not Available

  • Novartis Investigative Site

    Chambray Les Tours, 37170
    France

    Site Not Available

  • Novartis Investigative Site

    Chambray les Tours, 37175
    France

    Active - Recruiting

  • Novartis Investigative Site

    Champigny Sur Marne, 94507
    France

    Site Not Available

  • Novartis Investigative Site

    Cherbourg, 50102
    France

    Active - Recruiting

  • Novartis Investigative Site

    Cholet, 49325
    France

    Active - Recruiting

  • Novartis Investigative Site

    Clermont Ferrand, 63050
    France

    Site Not Available

  • Novartis Investigative Site

    Clermont-Ferrand, 63011
    France

    Active - Recruiting

  • Novartis Investigative Site

    Colmar Cedex, 68024
    France

    Site Not Available

  • Novartis Investigative Site

    Compiegne, 60321
    France

    Site Not Available

  • Novartis Investigative Site

    Compiegne cedex, 60321
    France

    Site Not Available

  • Novartis Investigative Site

    Corbeil Essonnes, 91100
    France

    Site Not Available

  • Novartis Investigative Site

    Creteil, 94000
    France

    Site Not Available

  • Novartis Investigative Site

    Dechy, 59187
    France

    Site Not Available

  • Novartis Investigative Site

    Dijon, 21000
    France

    Site Not Available

  • Novartis Investigative Site

    Dunkerque, 59240
    France

    Site Not Available

  • Novartis Investigative Site

    Eaubonne, 95600
    France

    Site Not Available

  • Novartis Investigative Site

    Frejus, 83608
    France

    Site Not Available

  • Novartis Investigative Site

    Gleize, 69400
    France

    Site Not Available

  • Novartis Investigative Site

    La Reunion, 97410
    France

    Site Not Available

  • Novartis Investigative Site

    La Roche sur Yon Cedex, 85925
    France

    Site Not Available

  • Novartis Investigative Site

    Libourne, 33505
    France

    Active - Recruiting

  • Novartis Investigative Site

    Lyon, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille, 13008
    France

    Active - Recruiting

  • Novartis Investigative Site

    Marseille Cedex 05, 13885
    France

    Site Not Available

  • Novartis Investigative Site

    Metz, 57085
    France

    Site Not Available

  • Novartis Investigative Site

    Metz Tessy, 74370
    France

    Site Not Available

  • Novartis Investigative Site

    Montpellier, 34070
    France

    Site Not Available

  • Novartis Investigative Site

    Nancy, 54000
    France

    Site Not Available

  • Novartis Investigative Site

    Neuilly Sur Seine, 92200
    France

    Site Not Available

  • Novartis Investigative Site

    Neuilly-sur-seine, 92200
    France

    Site Not Available

  • Novartis Investigative Site

    Nimes Cedex 9, 30029
    France

    Site Not Available

  • Novartis Investigative Site

    Niort, 79021
    France

    Site Not Available

  • Novartis Investigative Site

    Paris, 75970
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris 10, 75475
    France

    Active - Recruiting

  • Novartis Investigative Site

    Perpignan, 66000
    France

    Site Not Available

  • Novartis Investigative Site

    Pierre Benite, 69495
    France

    Site Not Available

  • Novartis Investigative Site

    Poitiers, 86021
    France

    Active - Recruiting

  • Novartis Investigative Site

    Pringy, 74374
    France

    Site Not Available

  • Novartis Investigative Site

    Reims, 51050
    France

    Site Not Available

  • Novartis Investigative Site

    Rouen, 76038
    France

    Site Not Available

  • Novartis Investigative Site

    ST Malo Cedex, 35403
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Dizier, 52100
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Etienne, 42100
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Herblain, 44805
    France

    Active - Recruiting

  • Novartis Investigative Site

    Saint Nazaire, 44600
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Pierre, 97410
    France

    Site Not Available

  • Novartis Investigative Site

    Saint-Herblain, 44805
    France

    Site Not Available

  • Novartis Investigative Site

    Sarcelles, 95200
    France

    Active - Recruiting

  • Novartis Investigative Site

    Soyaux, 16800
    France

    Site Not Available

  • Novartis Investigative Site

    St Etienne, 42030
    France

    Site Not Available

  • Novartis Investigative Site

    St Vallier, 71230
    France

    Site Not Available

  • Novartis Investigative Site

    Strasbourg cedex, 67085
    France

    Active - Recruiting

  • Novartis Investigative Site

    Suresnes, 92150
    France

    Active - Recruiting

  • Novartis Investigative Site

    Thionville, 57100
    France

    Site Not Available

  • Novartis Investigative Site

    Toulon La Seyne Sur Mer, 83056
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse, 31076
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse Cedex 3, 31076
    France

    Site Not Available

  • Novartis Investigative Site

    Valence, 26000
    France

    Site Not Available

  • Novartis Investigative Site

    Valenciennes, 59300
    France

    Site Not Available

  • Novartis Investigative Site

    Vandoeuvre-les-Nancy, 54519
    France

    Site Not Available

  • Novartis Investigative Site

    Vantoux, 57070
    France

    Active - Recruiting

  • Novartis Investigative Site

    Villejuif, 94800
    France

    Active - Recruiting

  • Novartis Investigative Site

    Villeurbanne, 69100
    France

    Site Not Available

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