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

NCT05697146

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Breast Cancer

Interventions: ribociclib + ET

Countries: France

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 overview

Sex: FEMALE

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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.

Locations (82)

Nice, Alpes Maritimes, France
Marseille, Bouches Du Rhone, France
Dijon, Cote D Or, France
Saint-Denis, France, France
Valenciennes, France, France
Saint-Cloud, Hauts De Seine, France
Grenoble, Isere, France
Reims, Marne, France
Toulon, Val De Marne, France
Amiens, France
Argenteuil, France
Avignon, France
Bayonne, France
Besançon, France
Béziers, France
Béziers, France
Brive-la-Gaillarde, France
Cannes, France
Carcassonne, France
Chalon-sur-Saône, France
Chambray-lès-Tours, France
Champigny-sur-Marne, France
Cherbourg, France
Cholet, France
Clermont-Ferrand, France
Clermont-Ferrand, France
Colmar, France
Compiègne, France
Compiègne, France
Corbeil-Essonnes, France
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