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French study tracks ribociclib use in over 1,000 breast cancer patients

NCT ID NCT05697146

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study watches how women with a certain type of advanced breast cancer are treated with the drug ribociclib in everyday medical practice in France. It does not give any new treatment but simply collects information on dosing, side effects, and how long the drug works. About 1,019 women are taking part, and the goal is to learn what happens when doctors prescribe this drug outside of a controlled trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,019 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Novartis Investigative Site

    Saint-Etienne, 42030, France

  • Novartis Investigative Site

    Saint-Etienne, 42100, France

  • Novartis Investigative Site

    Saint-Nazaire, 44600, France

  • Novartis Investigative Site

    Saint-Pierre, 97410, France

  • Novartis Investigative Site

    Saint-Vallier, 71230, France

  • Novartis Investigative Site

    Sarcelles, 95200, France

  • Novartis Investigative Site

    Soyaux, 16800, France

  • Novartis Investigative Site

    St-Malo, 35403, France

  • Novartis Investigative Site

    St-Malo, 35404, France

  • Novartis Investigative Site

    Suresnes, 92150, France

  • Novartis Investigative Site

    Thionville, 57100, France

  • Novartis Investigative Site

    Toulon La Seyne, 83056, France

  • Novartis Investigative Site

    Toulouse, 31076, France

  • Novartis Investigative Site

    Valence, 26000, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54519, France

  • Novartis Investigative Site

    Vantoux, 57070, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Villeurbanne, 69100, France

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189, France

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915, France

  • Novartis Investigative Site

    Dijon, Cote D Or, 21034, France

  • Novartis Investigative Site

    Saint-Denis, France, 97490, France

  • Novartis Investigative Site

    Valenciennes, France, 59300, France

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, 92210, France

  • Novartis Investigative Site

    Grenoble, Isere, 38028, France

  • Novartis Investigative Site

    Reims, Marne, 51056, France

  • Novartis Investigative Site

    Toulon, Val De Marne, 83800, France

  • Novartis Investigative Site

    Amiens, 80000, France

  • Novartis Investigative Site

    Argenteuil, 95107, France

  • Novartis Investigative Site

    Avignon, 84082, France

  • Novartis Investigative Site

    Bayonne, 64100, France

  • Novartis Investigative Site

    Besançon, 25030, France

  • Novartis Investigative Site

    Béziers, 34500, France

  • Novartis Investigative Site

    Béziers, 34535, France

  • Novartis Investigative Site

    Brive-la-Gaillarde, 19100, France

  • Novartis Investigative Site

    Cannes, 06414, France

  • Novartis Investigative Site

    Carcassonne, 11000, France

  • Novartis Investigative Site

    Chalon-sur-Saône, 71321, France

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170, France

  • Novartis Investigative Site

    Champigny-sur-Marne, 94507, France

  • Novartis Investigative Site

    Cherbourg, 50102, France

  • Novartis Investigative Site

    Cholet, 49325, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63050, France

  • Novartis Investigative Site

    Colmar, 68024, France

  • Novartis Investigative Site

    Compiègne, 60200, France

  • Novartis Investigative Site

    Compiègne, 60321, France

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100, France

  • Novartis Investigative Site

    Créteil, 94000, France

  • Novartis Investigative Site

    Dechy, 59187, France

  • Novartis Investigative Site

    Dijon, 21000, France

  • Novartis Investigative Site

    Dunkirk, 59240, France

  • Novartis Investigative Site

    Eaubonne, 95600, France

  • Novartis Investigative Site

    Fréjus, 83608, France

  • Novartis Investigative Site

    Gleizé, 69400, France

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925, France

  • Novartis Investigative Site

    Libourne, 33505, France

  • Novartis Investigative Site

    Lyon, 69337, France

  • Novartis Investigative Site

    Lyon 08, 69373, France

  • Novartis Investigative Site

    Marseille, 13008, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Metz, 57070, France

  • Novartis Investigative Site

    Metz, 57085, France

  • Novartis Investigative Site

    Metz-Tessy, 74374, France

  • Novartis Investigative Site

    Montbelliard, 25200, France

  • Novartis Investigative Site

    Montpellier, 34070, France

  • Novartis Investigative Site

    Nancy, 54000, France

  • Novartis Investigative Site

    Neuilly-sur-Seine, 92200, France

  • Novartis Investigative Site

    Niort, 79021, France

  • Novartis Investigative Site

    Nîmes, 30029, France

  • Novartis Investigative Site

    Osny, 95520, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Paris, 75970, France

  • Novartis Investigative Site

    Perpignan, 66000, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Reims, 51050, France

  • Novartis Investigative Site

    Rouen, 76038, France

  • Novartis Investigative Site

    Rouen, 76100, France

  • Novartis Investigative Site

    Saint-Dizier, 52100, France

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