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

March 13, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1019

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • France
      • Amiens, France, 80000
        • Novartis Investigative Site
      • Argenteuil, France, 95107
        • Novartis Investigative Site
      • Avignon, France, 84082
        • Novartis Investigative Site
      • Bayonne, France, 64100
        • Novartis Investigative Site
      • Besançon, France, 25030
        • Novartis Investigative Site
      • Brive-la-Gaillarde, France, 19100
        • Novartis Investigative Site
      • Béziers, France, 34500
        • Novartis Investigative Site
      • Béziers, France, 34535
        • Novartis Investigative Site
      • Cannes, France, 06414
        • Novartis Investigative Site
      • Carcassonne, France, 11000
        • Novartis Investigative Site
      • Chalon-sur-Saône, France, 71321
        • Novartis Investigative Site
      • Chambray-lès-Tours, France, 37170
        • Novartis Investigative Site
      • Champigny-sur-Marne, France, 94507
        • Novartis Investigative Site
      • Cherbourg, France, 50102
        • Novartis Investigative Site
      • Cholet, France, 49325
        • Novartis Investigative Site
      • Clermont-Ferrand, France, 63011
        • Novartis Investigative Site
      • Clermont-Ferrand, France, 63050
        • Novartis Investigative Site
      • Colmar, France, 68024
        • Novartis Investigative Site
      • Compiègne, France, 60321
        • Novartis Investigative Site
      • Compiègne, France, 60200
        • Novartis Investigative Site
      • Corbeil-Essonnes, France, 91100
        • Novartis Investigative Site
      • Créteil, France, 94000
        • Novartis Investigative Site
      • Dechy, France, 59187
        • Novartis Investigative Site
      • Dijon, France, 21000
        • Novartis Investigative Site
      • Dunkirk, France, 59240
        • Novartis Investigative Site
      • Eaubonne, France, 95600
        • Novartis Investigative Site
      • Fréjus, France, 83608
        • Novartis Investigative Site
      • Gleizé, France, 69400
        • Novartis Investigative Site
      • La Roche-sur-Yon, France, 85925
        • Novartis Investigative Site
      • Libourne, France, 33505
        • Novartis Investigative Site
      • Lyon, France, 69337
        • Novartis Investigative Site
      • Lyon 08, France, 69373
        • Novartis Investigative Site
      • Marseille, France, 13273
        • Novartis Investigative Site
      • Marseille, France, 13008
        • Novartis Investigative Site
      • Marseille, France, 13885
        • Novartis Investigative Site
      • Metz, France, 57085
        • Novartis Investigative Site
      • Metz, France, 57070
        • Novartis Investigative Site
      • Metz-Tessy, France, 74374
        • Novartis Investigative Site
      • Montbelliard, France, 25200
        • Novartis Investigative Site
      • Montpellier, France, 34070
        • Novartis Investigative Site
      • Nancy, France, 54000
        • Novartis Investigative Site
      • Neuilly-sur-Seine, France, 92200
        • Novartis Investigative Site
      • Niort, France, 79021
        • Novartis Investigative Site
      • Nîmes, France, 30029
        • Novartis Investigative Site
      • Osny, France, 95520
        • Novartis Investigative Site
      • Paris, France, 75970
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Paris, France, 75475
        • Novartis Investigative Site
      • Perpignan, France, 66000
        • Novartis Investigative Site
      • Pierre-Bénite, France, 69495
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Novartis Investigative Site
      • Reims, France, 51050
        • Novartis Investigative Site
      • Rouen, France, 76100
        • Novartis Investigative Site
      • Rouen, France, 76038
        • Novartis Investigative Site
      • Saint-Dizier, France, 52100
        • Novartis Investigative Site
      • Saint-Etienne, France, 42030
        • Novartis Investigative Site
      • Saint-Etienne, France, 42100
        • Novartis Investigative Site
      • Saint-Nazaire, France, 44600
        • Novartis Investigative Site
      • Saint-Pierre, France, 97410
        • Novartis Investigative Site
      • Saint-Vallier, France, 71230
        • Novartis Investigative Site
      • Sarcelles, France, 95200
        • Novartis Investigative Site
      • Soyaux, France, 16800
        • Novartis Investigative Site
      • St-Malo, France, 35403
        • Novartis Investigative Site
      • St-Malo, France, 35404
        • Novartis Investigative Site
      • Suresnes, France, 92150
        • Novartis Investigative Site
      • Thionville, France, 57100
        • Novartis Investigative Site
      • Toulon La Seyne, France, 83056
        • Novartis Investigative Site
      • Toulouse, France, 31076
        • Novartis Investigative Site
      • Valence, France, 26000
        • Novartis Investigative Site
      • Vandœuvre-lès-Nancy, France, 54519
        • Novartis Investigative Site
      • Vantoux, France, 57070
        • Novartis Investigative Site
      • Villejuif, France, 94800
        • Novartis Investigative Site
      • Villeurbanne, France, 69100
        • Novartis Investigative Site
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06189
        • Novartis Investigative Site
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13915
        • Novartis Investigative Site
    • Cote D Or
      • Dijon, Cote D Or, France, 21034
        • Novartis Investigative Site
    • France
      • Saint-Denis, France, France, 97490
        • Novartis Investigative Site
      • Valenciennes, France, France, 59300
        • Novartis Investigative Site
    • Hauts De Seine
      • Saint-Cloud, Hauts De Seine, France, 92210
        • Novartis Investigative Site
    • Isere
      • Grenoble, Isere, France, 38028
        • Novartis Investigative Site
    • Marne
      • Reims, Marne, France, 51056
        • Novartis Investigative Site
    • Val De Marne
      • Toulon, Val De Marne, France, 83800
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ribociclib + ET
Women prescribed ribociclib + Endocrine Therapy (ET)
Other: ribociclib + ET
There is no treatment allocation. Patients administered ribociclib + endocrine Therapy (ET) by prescription will be enrolled.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients by initial dose of ribociclib
Time Frame: Baseline
Proportion of patients by initial dose of ribociclib to be collected
Baseline
Proportion of patients by endocrine therapy partner
Time Frame: Baseline, up to 54 months
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
Time Frame: Baseline
Proportion of patients for each line of treatment with ribociclib (1L, 2L, >2L) to be collected
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) by treatment line and endocrine partner
Time Frame: month 12, month 24, month 36, up to 54 months
Progression free survival (PFS): time from the date of treatment initiation with ribociclib to the date of the first documented disease progression or death due to any cause, whichever occurs first; if a patient has not had an event, the PFS will be censored at the date of the last adequate tumor assessment (RECIST 1.1).
month 12, month 24, month 36, up to 54 months
Overall Survival (OS)
Time Frame: month 12, month 24, month 36, up to 54 months
Overall survival: time from the date of treatment initiation with ribociclib until death due to any cause; if a patient is not known to have died, then the OS will be censored at the latest date the patient was known to be alive.
month 12, month 24, month 36, up to 54 months
Identify prognostic factors influencing the OS and PFS
Time Frame: Up to 54 months
Prognostic factors influencing the OS and PFS will be listed
Up to 54 months
Proportion of patients with adjuvant treatment and type of treatment
Time Frame: Up to 54 months
Proportion of patients with adjuvant treatment and type of treatment to be collected
Up to 54 months
Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment
Time Frame: Up to 54 months
Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment to be collected
Up to 54 months
Proportion of patients by menopausal status
Time Frame: Up to 54 months
Proportion of patients by menopausal status (pre-/perimenopausal patients versus postmenopausal patients)
Up to 54 months
Proportion of de novo metastatic patients, 1L, 2L and >2L at ribociclib initiation
Time Frame: Up to 54 months
Proportion of de novo metastatic patients, 1L, 2L and >2L at ribociclib initiation to be collected
Up to 54 months
Proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown
Time Frame: Up to 54 months
Proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown to be collected
Up to 54 months
Overall response rate
Time Frame: Up to 54 months
Overall response rate, defined as the proportion of patients with best overall response or complete response (CR) or partial response (PR) according to RECIST 1.1.
Up to 54 months
In the subgroup of patients with visceral metastasis: median PFS
Time Frame: Up to 54 months
Progression free survival (PFS): time from the date of treatment initiation with ribociclib to the date of the first documented disease progression or death due to any cause, whichever occurs first; if a patient has not had an event, the PFS will be censored at the date of the last adequate tumor assessment (RECIST 1.1).
Up to 54 months
In the subgroup of patients with visceral metastasis: PFS rate
Time Frame: Up to 54 months
Progression free survival (PFS): time from the date of treatment initiation with ribociclib to the date of the first documented disease progression or death due to any cause, whichever occurs first; if a patient has not had an event, the PFS will be censored at the date of the last adequate tumor assessment (RECIST 1.1).
Up to 54 months
In the subgroup of patients with visceral metastasis: median OS
Time Frame: Up to 54 months
Overall survival: time from the date of treatment initiation with ribociclib until death due to any cause; if a patient is not known to have died, then the OS will be censored at the latest date the patient was known to be alive.
Up to 54 months
In the subgroup of patients with visceral metastasis: OS rate
Time Frame: Up to 54 months
Overall survival: time from the date of treatment initiation with ribociclib until death due to any cause; if a patient is not known to have died, then the OS will be censored at the latest date the patient was known to be alive.
Up to 54 months
In the subgroup of patients with visceral metastasis: proportion of patients with CR/PR/SD/PD/unknown
Time Frame: Up to 54 months
In the subgroup of patients with visceral metastasis: proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown to be collected
Up to 54 months
Sequential PFS (S-PFS)
Time Frame: month 12, month 24, month 36, up to 54 months
Sequential progression free survival: time from the date of treatment initiation with ribociclib to the date of the second and subsequent documented progression or death due to any cause, whichever occurs first.
month 12, month 24, month 36, up to 54 months
Time to chemotherapy since ribociclib initiation
Time Frame: Up to 54 months
Time to chemotherapy since ribociclib initiation to be collected
Up to 54 months
Proportion of patients with ribociclib dose adjustment after treatment initiation and reason(s)
Time Frame: Up to 54 months
Proportion of patients with ribociclib dose adjustment after treatment initiation; adjustment type (dose modifications/interruptions during treatment) and reason(s) for dose modifications/interruptions).
Up to 54 months
Treatment exposure to ribociclib
Time Frame: Up to 54 months
Treatment exposure to ribociclib: time from treatment initiation to treatment discontinuation.
Up to 54 months
Reason(s) for discontinuation
Time Frame: Up to 54 months
Treatment discontinuation: permanent cessation of the treatment received, for any reason.
Up to 54 months
In the subgroup of oligometastatic patients at inclusion: proportion of patients treated with local treatment
Time Frame: Up to 54 months
In the subgroup of oligometastatic patients at inclusion: proportion of patients treated with local treatment and treatment outcome to be collected
Up to 54 months
Proportion of visits in the site versus proportion of remote visits
Time Frame: Up to 54 months
Proportion of visits in the site versus proportion of remote visits to be collected
Up to 54 months
Proportion of patients with at least one hospitalization
Time Frame: Up to 54 months
Proportion of patients with at least one hospitalization to be collected
Up to 54 months
EuroQol 5-Dimension Questionnaire5-level version (EQ-5D-5L) scores
Time Frame: Up to 54 months
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Up to 54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLEE011AFR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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