NCT05697146Active, not recruiting
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France: a National, Multicenter, Prospective, Non-interventional Study
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1019 (actual)
- First submitted
- 8 Nov 2022
- Start date
- 13 Dec 2022
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05697146
What you commit to
- Study type: Observational
- Participants enrolled: 1019
- From 13 Dec 2022 to the primary completion date, 30 Jun 2028
- 68 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients for whom AI or fulvestrant in monotherapy has been initiated \> 28 days before inclusion.
- Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC.
Other
- Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion.
- Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion.
- Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.
Who the study is looking for
- Patients who meet all of the following criteria will be included in the RosaLEE study:
- Adult women aged ≥ 18 years old at inclusion.
- 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.
Age in the registry: 18 years to 99 years · Sex: Female · Does not accept healthy volunteers
Sites (68)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Argenteuil | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Béziers | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Brive-la-Gaillarde | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Cannes | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Carcassonne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Chalon-sur-Saône | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Champigny-sur-Marne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Cherbourg | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Cholet | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Colmar | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Compiègne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Dechy | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Dunkirk | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Eaubonne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Fréjus | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Gleizé | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Libourne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Lyon 08 | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Metz | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Metz-Tessy | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Montbelliard | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Niort | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Osny | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Perpignan | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Cloud | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Dizier | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Nazaire | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Pierre | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Vallier | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sarcelles | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Soyaux | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | St-Malo | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Thionville | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toulon La Seyne | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Valence | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Valenciennes | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Vantoux | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Villeurbanne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.