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

NCT ID: NCT05697146

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1018 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-13

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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HR+/HER2- advanced or metastatic breast cancer RosaLEE NIS France Ribociclib

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ribociclib + ET

Women prescribed ribociclib + Endocrine Therapy (ET)

ribociclib + ET

Intervention Type OTHER

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

Interventions

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ribociclib + ET

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nice, Alpes Maritimes, France

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Novartis Investigative Site

Marseille, Bouches Du Rhone, France

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Novartis Investigative Site

Dijon, Cote D Or, France

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Saint-Denis, France, France

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Valenciennes, France, France

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Saint-Cloud, Hauts De Seine, France

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Grenoble, Isere, France

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Reims, Marne, France

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Toulon, Val De Marne, France

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Amiens, , France

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Argenteuil, , France

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Avignon, , France

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Besançon, , France

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Béziers, , France

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Béziers, , France

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Cannes, , France

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Carcassonne, , France

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Chalon-sur-Saône, , France

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Chambray-lès-Tours, , France

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Champigny-sur-Marne, , France

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Cherbourg, , France

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Cholet, , France

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Clermont-Ferrand, , France

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Clermont-Ferrand, , France

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Colmar, , France

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Compiègne, , France

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Compiègne, , France

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Corbeil-Essonnes, , France

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Créteil, , France

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Dechy, , France

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Dijon, , France

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Dunkirk, , France

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Eaubonne, , France

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Fréjus, , France

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Gleizé, , France

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La Roche-sur-Yon, , France

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Libourne, , France

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Lyon, , France

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Marseille, , France

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Marseille, , France

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Marseille, , France

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Metz, , France

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Metz, , France

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Metz-Tessy, , France

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Montbelliard, , France

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Montpellier, , France

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Nancy, , France

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Neuilly-sur-Seine, , France

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Niort, , France

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Nîmes, , France

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Osny, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Perpignan, , France

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Pierre-Bénite, , France

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Poitiers, , France

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Reims, , France

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Rouen, , France

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Rouen, , France

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Saint-Dizier, , France

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Saint-Etienne, , France

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Saint-Etienne, , France

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Saint-Nazaire, , France

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Saint-Pierre, , France

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Saint-Vallier, , France

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Sarcelles, , France

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Soyaux, , France

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St-Malo, , France

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St-Malo, , France

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Suresnes, , France

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Thionville, , France

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Toulon La Seyne, , France

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Toulouse, , France

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Valence, , France

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Vandœuvre-lès-Nancy, , France

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Vantoux, , France

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Villejuif, , France

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Novartis Investigative Site

Villeurbanne, , France

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Countries

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France

Other Identifiers

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CLEE011AFR01

Identifier Type: -

Identifier Source: org_study_id