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

Breast Cancer Clinical Trial

— RosaLEE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697146
• Other study ID #: CLEE011AFR01
• Status: Recruiting
• Start date: December 13, 2022
• Est. completion date: June 28, 2027

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 482
• Est. completion date: June 28, 2027
• Est. primary completion date: June 28, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• ribociclib + ET
There is no treatment allocation. Patients administered ribociclib + endocrine Therapy (ET) by prescription will be enrolled.

Locations

Country	Name	City	State
France	Novartis Investigative Site	Argenteuil
France	Novartis Investigative Site	Avignon
France	Novartis Investigative Site	Bayonne
France	Novartis Investigative Site	Besancon Cedex
France	Novartis Investigative Site	Beziers
France	Novartis Investigative Site	Beziers
France	Novartis Investigative Site	Cannes
France	Novartis Investigative Site	Carcassonne
France	Novartis Investigative Site	Chalon sur Saône
France	Novartis Investigative Site	Chambray Les Tours
France	Novartis Investigative Site	Champigny Sur Marne
France	Novartis Investigative Site	Cherbourg
France	Novartis Investigative Site	Cholet
France	Novartis Investigative Site	Clermont Ferrand
France	Novartis Investigative Site	Clermont Ferrand
France	Novartis Investigative Site	Colmar Cedex
France	Novartis Investigative Site	Compiegne
France	Novartis Investigative Site	Compiegne cedex
France	Novartis Investigative Site	Corbeil Essonnes
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Dechy
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Dunkerque
France	Novartis Investigative Site	Eaubonne
France	Novartis Investigative Site	Frejus
France	Novartis Investigative Site	Gleize
France	Novartis Investigative Site	Grenoble Cedex 1	Isere
France	Novartis Investigative Site	La Reunion
France	Novartis Investigative Site	La Roche sur Yon Cedex
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille Cedex 05
France	Novartis Investigative Site	Metz
France	Novartis Investigative Site	Metz
France	Novartis Investigative Site	Metz Tessy
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nancy
France	Novartis Investigative Site	Neuilly-sur-seine
France	Novartis Investigative Site	Nice Cedex 2	Alpes Maritimes
France	Novartis Investigative Site	Nimes Cedex 9
France	Novartis Investigative Site	Niort
France	Novartis Investigative Site	Perpignan
France	Novartis Investigative Site	Pierre Benite
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Reims	Marne
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Saint Dizier
France	Novartis Investigative Site	Saint Etienne
France	Novartis Investigative Site	Saint Nazaire
France	Novartis Investigative Site	Saint-Cloud	Hauts De Seine
France	Novartis Investigative Site	Sarcelles
France	Novartis Investigative Site	Soyaux
France	Novartis Investigative Site	St Etienne
France	Novartis Investigative Site	ST Malo Cedex
France	Novartis Investigative Site	St Vallier
France	Novartis Investigative Site	Strasbourg cedex
France	Novartis Investigative Site	Thionville
France	Novartis Investigative Site	Toulon Cedex 9	Val De Marne
France	Novartis Investigative Site	Toulon La Seyne Sur Mer
France	Novartis Investigative Site	Toulouse Cedex 3
France	Novartis Investigative Site	Valence
France	Novartis Investigative Site	Valenciennes
France	Novartis Investigative Site	Vandoeuvre-les-Nancy
France	Novartis Investigative Site	Villejuif
France	Novartis Investigative Site	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients by initial dose of ribociclib	Proportion of patients by initial dose of ribociclib to be collected	Baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	Identify prognostic factors influencing the OS and PFS	Prognostic factors influencing the OS and PFS will be listed	Up to 54 months
Secondary	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
Secondary	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
Secondary	Proportion of patients by menopausal status	Proportion of patients by menopausal status (pre-/perimenopausal patients versus postmenopausal patients)	Up to 54 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to chemotherapy since ribociclib initiation	Time to chemotherapy since ribociclib initiation to be collected	Up to 54 months
Secondary	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
Secondary	Treatment exposure to ribociclib	Treatment exposure to ribociclib: time from treatment initiation to treatment discontinuation.	Up to 54 months
Secondary	Reason(s) for discontinuation	Treatment discontinuation: permanent cessation of the treatment received, for any reason.	Up to 54 months
Secondary	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
Secondary	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
Secondary	Proportion of patients with at least one hospitalization	Proportion of patients with at least one hospitalization to be collected	Up to 54 months
Secondary	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