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

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: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: ribociclib + ET

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: Observational
• Enrollment (Estimated): 482

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• France
  • Argenteuil, France, 95107
    • Active, not recruiting
    • Novartis Investigative Site
  • Avignon, France, 84082
    • Active, not recruiting
    • Novartis Investigative Site
  • Bayonne, France, 64100
    • Active, not recruiting
    • Novartis Investigative Site
  • Besancon Cedex, France, 25030
    • Recruiting
    • Novartis Investigative Site
  • Beziers, France, 34535
    • Recruiting
    • Novartis Investigative Site
  • Beziers, France, 34500
    • Active, not recruiting
    • Novartis Investigative Site
  • Cannes, France, 06414
    • Recruiting
    • Novartis Investigative Site
  • Carcassonne, France, 11000
    • Active, not recruiting
    • Novartis Investigative Site
  • Chalon sur Saône, France, 71321
    • Recruiting
    • Novartis Investigative Site
  • Chambray Les Tours, France, 37170
    • Active, not recruiting
    • Novartis Investigative Site
  • Champigny Sur Marne, France, 94507
    • Active, not recruiting
    • Novartis Investigative Site
  • Cherbourg, France, 50102
    • Recruiting
    • Novartis Investigative Site
  • Cholet, France, 49325
    • Recruiting
    • Novartis Investigative Site
  • Clermont Ferrand, France, 63011
    • Recruiting
    • Novartis Investigative Site
  • Clermont Ferrand, France, 63050
    • Active, not recruiting
    • Novartis Investigative Site
  • Colmar Cedex, France, 68024
    • Active, not recruiting
    • Novartis Investigative Site
  • Compiegne, France, 60200
    • Active, not recruiting
    • Novartis Investigative Site
  • Compiegne cedex, France, 60321
    • Active, not recruiting
    • Novartis Investigative Site
  • Corbeil Essonnes, France, 91100
    • Active, not recruiting
    • Novartis Investigative Site
  • Creteil, France, 94000
    • Active, not recruiting
    • Novartis Investigative Site
  • Dechy, France, 59187
    • Active, not recruiting
    • Novartis Investigative Site
  • Dijon, France, 21000
    • Active, not recruiting
    • Novartis Investigative Site
  • Dunkerque, France, 59240
    • Active, not recruiting
    • Novartis Investigative Site
  • Eaubonne, France, 95600
    • Active, not recruiting
    • Novartis Investigative Site
  • Frejus, France, 83608
    • Active, not recruiting
    • Novartis Investigative Site
  • Gleize, France, 69400
    • Active, not recruiting
    • Novartis Investigative Site
  • La Reunion, France, 97410
    • Active, not recruiting
    • Novartis Investigative Site
  • La Roche sur Yon Cedex, France, 85925
    • Active, not recruiting
    • Novartis Investigative Site
  • Lyon, France, 69373
    • Active, not recruiting
    • Novartis Investigative Site
  • Marseille, France, 13273
    • Recruiting
    • Novartis Investigative Site
  • Marseille, France, 13008
    • Recruiting
    • Novartis Investigative Site
  • Marseille Cedex 05, France, 13885
    • Recruiting
    • Novartis Investigative Site
  • Metz, France, 57085
    • Active, not recruiting
    • Novartis Investigative Site
  • Metz, France, 57070
    • Active, not recruiting
    • Novartis Investigative Site
  • Metz Tessy, France, 74370
    • Active, not recruiting
    • Novartis Investigative Site
  • Montpellier, France, 34070
    • Active, not recruiting
    • Novartis Investigative Site
  • Nancy, France, 54000
    • Active, not recruiting
    • Novartis Investigative Site
  • Neuilly-sur-seine, France, 92200
    • Active, not recruiting
    • Novartis Investigative Site
  • Nimes Cedex 9, France, 30029
    • Active, not recruiting
    • Novartis Investigative Site
  • Niort, France, 79021
    • Active, not recruiting
    • Novartis Investigative Site
  • Perpignan, France, 66000
    • Active, not recruiting
    • Novartis Investigative Site
  • Pierre Benite, France, 69495
    • Active, not recruiting
    • Novartis Investigative Site
  • Poitiers, France, 86000
    • Recruiting
    • Novartis Investigative Site
  • Reims, France, 51050
    • Active, not recruiting
    • Novartis Investigative Site
  • Rouen, France, 76038
    • Active, not recruiting
    • Novartis Investigative Site
  • Rouen, France, 76100
    • Active, not recruiting
    • Novartis Investigative Site
  • ST Malo Cedex, France, 35403
    • Active, not recruiting
    • Novartis Investigative Site
  • Saint Dizier, France, 52100
    • Active, not recruiting
    • Novartis Investigative Site
  • Saint Etienne, France, 42100
    • Active, not recruiting
    • Novartis Investigative Site
  • Saint Nazaire, France, 44600
    • Active, not recruiting
    • Novartis Investigative Site
  • Sarcelles, France, 95200
    • Recruiting
    • Novartis Investigative Site
  • Soyaux, France, 16800
    • Active, not recruiting
    • Novartis Investigative Site
  • St Etienne, France, 42030
    • Active, not recruiting
    • Novartis Investigative Site
  • St Vallier, France, 71230
    • Active, not recruiting
    • Novartis Investigative Site
  • Strasbourg cedex, France, 67085
    • Recruiting
    • Novartis Investigative Site
  • Thionville, France, 57100
    • Active, not recruiting
    • Novartis Investigative Site
  • Toulon La Seyne Sur Mer, France, 83056
    • Active, not recruiting
    • Novartis Investigative Site
  • Toulouse Cedex 3, France, 31076
    • Active, not recruiting
    • Novartis Investigative Site
  • Valence, France, 26000
    • Active, not recruiting
    • Novartis Investigative Site
  • Valenciennes, France, 59300
    • Active, not recruiting
    • Novartis Investigative Site
  • Vandoeuvre-les-Nancy, France, 54519
    • Active, not recruiting
    • Novartis Investigative Site
  • Villejuif, France, 94800
    • Recruiting
    • Novartis Investigative Site
  • Villeurbanne, France, 69100
    • Active, not recruiting
    • Novartis Investigative Site
  • Alpes Maritimes
    • Nice Cedex 2, Alpes Maritimes, France, 06189
      • Active, not recruiting
      • Novartis Investigative Site
  • Hauts De Seine
    • Saint-Cloud, Hauts De Seine, France, 92210
      • Active, not recruiting
      • Novartis Investigative Site
  • Isere
    • Grenoble Cedex 1, Isere, France, 38028
      • Active, not recruiting
      • Novartis Investigative Site
  • Marne
    • Reims, Marne, France, 51056
      • Active, not recruiting
      • Novartis Investigative Site
  • Val De Marne
    • Toulon Cedex 9, Val De Marne, France, 83800
      • Active, not recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) by treatment line and endocrine partner	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)	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	Prognostic factors influencing the OS and PFS will be listed	Up to 54 months
Proportion of patients with adjuvant treatment and type of treatment	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	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	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	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	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	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	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	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	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	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	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)	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 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)	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	Treatment exposure to ribociclib: time from treatment initiation to treatment discontinuation.	Up to 54 months
Reason(s) for discontinuation	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	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	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	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	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

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 28, 2027

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: NIS; Ribociclib; France; HR+/HER2- advanced or metastatic breast cancer; RosaLEE
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011AFR01