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Observing treatment patterns and outcomes for women with advanced 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

Observational Novartis · NCT05697146

This study looks at how women with advanced breast cancer in France are treated with ribociclib and hormone therapy to see what happens to them over the next 4.5 years.

Quick facts

Study typeObservational
Enrollment482 (estimated)
Ages18 Years to 99 Years
SexFemale
SponsorNovartis Industry-sponsored
Locations78 sites (Nice, Alpes Maritimes and 77 other locations)
Trial IDNCT05697146 on ClinicalTrials.gov

What this trial studies

This national, multicenter, prospective, non-interventional study focuses on women with HR+/HER2- locally advanced or metastatic breast cancer who have already made a clinical decision to start treatment with ribociclib and endocrine therapy. Patients will be followed for a total of 4.5 years, which includes 18 months of patient inclusion and 3 years of follow-up, regardless of whether they continue treatment. The study aims to gather real-world data on treatment patterns and clinical outcomes in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adult women aged 18 and older with HR+/HER2- locally advanced or metastatic breast cancer who have decided to initiate ribociclib and endocrine therapy.

Not a fit: Patients who have previously started treatment with ribociclib or other specified therapies before inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of ribociclib combined with endocrine therapy for women with advanced breast cancer.

How similar studies have performed: While this study is observational and builds on existing treatment patterns, similar studies have shown success in understanding real-world treatment outcomes in oncology.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Nice, Alpes Maritimes and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerHR+/HER2- advanced or metastatic breast cancerRosaLEENISFranceRibociclib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.