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

NCT05697146 | Active Not Recruiting

• 1 other identifier: CLEE011AFR01
• Study Type: observational
• Target: 1,019
• Locations: 1 country
• Sites: 82

Brief 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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Proportion of patients by initial dose of ribociclib

  Proportion of patients by initial dose of ribociclib to be collected

  Baseline

• Proportion of patients by endocrine therapy partner

  Proportion of patients by endocrine therapy partner to be collected(e.g., tamoxifen, letrozole, fulvestrant, anastrozole, exemestane, LHRH agonist)

  Baseline, up to 54 months

• Proportion of patients for each line of treatment with ribociclib

  Proportion of patients for each line of treatment with ribociclib (1L, 2L, \>2L) to be collected

  Baseline

Secondary Outcomes (23)

• Progression Free Survival (PFS) by treatment line and endocrine partner

  month 12, month 24, month 36, up to 54 months

• Overall Survival (OS)

  month 12, month 24, month 36, up to 54 months

• Identify prognostic factors influencing the OS and PFS

  Up to 54 months

• Proportion of patients with adjuvant treatment and type of treatment

  Up to 54 months

• Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment

  Up to 54 months

Study Arms (1)

ribociclib + ET

Women prescribed ribociclib + Endocrine Therapy (ET)

Other: ribociclib + ET

Interventions

ribociclib + ET OTHER

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

ribociclib + ET

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Pre-/perimenopausal and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced HR+/HER2- breast cancer population treated with ribociclib in France

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (82)

Novartis Investigative Site

Nice, Alpes Maritimes, 06189, France

Location

Novartis Investigative Site

Marseille, Bouches Du Rhone, 13915, France

Location

Novartis Investigative Site

Dijon, Cote D Or, 21034, France

Location

Novartis Investigative Site

Saint-Denis, France, 97490, France

Location

Novartis Investigative Site

Valenciennes, France, 59300, France

Location

Novartis Investigative Site

Saint-Cloud, Hauts De Seine, 92210, France

Location

Novartis Investigative Site

Grenoble, Isere, 38028, France

Location

Novartis Investigative Site

Reims, Marne, 51056, France

Location

Novartis Investigative Site

Toulon, Val De Marne, 83800, France

Location

Novartis Investigative Site

Amiens, 80000, France

Location

Novartis Investigative Site

Argenteuil, 95107, France

Location

Novartis Investigative Site

Avignon, 84082, France

Location

Novartis Investigative Site

Bayonne, 64100, France

Location

Novartis Investigative Site

Besançon, 25030, France

Location

Novartis Investigative Site

Béziers, 34500, France

Location

Novartis Investigative Site

Béziers, 34535, France

Location

Novartis Investigative Site

Brive-la-Gaillarde, 19100, France

Location

Novartis Investigative Site

Cannes, 06414, France

Location

Novartis Investigative Site

Carcassonne, 11000, France

Location

Novartis Investigative Site

Chalon-sur-Saône, 71321, France

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Novartis Investigative Site

Chambray-lès-Tours, 37170, France

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Novartis Investigative Site

Champigny-sur-Marne, 94507, France

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Novartis Investigative Site

Cherbourg, 50102, France

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Novartis Investigative Site

Cholet, 49325, France

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Novartis Investigative Site

Clermont-Ferrand, 63011, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63050, France

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Novartis Investigative Site

Colmar, 68024, France

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Novartis Investigative Site

Compiègne, 60200, France

Location

Novartis Investigative Site

Compiègne, 60321, France

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Novartis Investigative Site

Corbeil-Essonnes, 91100, France

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Novartis Investigative Site

Créteil, 94000, France

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Novartis Investigative Site

Dechy, 59187, France

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Novartis Investigative Site

Dijon, 21000, France

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Novartis Investigative Site

Dunkirk, 59240, France

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Novartis Investigative Site

Eaubonne, 95600, France

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Novartis Investigative Site

Fréjus, 83608, France

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Novartis Investigative Site

Gleizé, 69400, France

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Novartis Investigative Site

La Roche-sur-Yon, 85925, France

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Novartis Investigative Site

Libourne, 33505, France

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Novartis Investigative Site

Lyon, 69337, France

Location

Novartis Investigative Site

Lyon 08, 69373, France

Location

Novartis Investigative Site

Marseille, 13008, France

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Marseille, 13885, France

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Novartis Investigative Site

Metz, 57070, France

Location

Novartis Investigative Site

Metz, 57085, France

Location

Novartis Investigative Site

Metz-Tessy, 74374, France

Location

Novartis Investigative Site

Montbelliard, 25200, France

Location

Novartis Investigative Site

Montpellier, 34070, France

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Novartis Investigative Site

Nancy, 54000, France

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Novartis Investigative Site

Neuilly-sur-Seine, 92200, France

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Novartis Investigative Site

Niort, 79021, France

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Novartis Investigative Site

Nîmes, 30029, France

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Novartis Investigative Site

Osny, 95520, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Paris, 75475, France

Location

Novartis Investigative Site

Paris, 75970, France

Location

Novartis Investigative Site

Perpignan, 66000, France

Location

Novartis Investigative Site

Pierre-Bénite, 69495, France

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Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Reims, 51050, France

Location

Novartis Investigative Site

Rouen, 76038, France

Location

Novartis Investigative Site

Rouen, 76100, France

Location

Novartis Investigative Site

Saint-Dizier, 52100, France

Location

Novartis Investigative Site

Saint-Etienne, 42030, France

Location

Novartis Investigative Site

Saint-Etienne, 42100, France

Location

Novartis Investigative Site

Saint-Nazaire, 44600, France

Location

Novartis Investigative Site

Saint-Pierre, 97410, France

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Novartis Investigative Site

Saint-Vallier, 71230, France

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Novartis Investigative Site

Sarcelles, 95200, France

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Novartis Investigative Site

Soyaux, 16800, France

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Novartis Investigative Site

St-Malo, 35403, France

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Novartis Investigative Site

St-Malo, 35404, France

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Novartis Investigative Site

Suresnes, 92150, France

Location

Novartis Investigative Site

Thionville, 57100, France

Location

Novartis Investigative Site

Toulon La Seyne, 83056, France

Location

Novartis Investigative Site

Toulouse, 31076, France

Location

Novartis Investigative Site

Valence, 26000, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54519, France

Location

Novartis Investigative Site

Vantoux, 57070, France

Location

Novartis Investigative Site

Villejuif, 94800, France

Location

Novartis Investigative Site

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: January 25, 2023
• Study Start: December 13, 2022
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (82)