Clinical trial NCT05697146: Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: HR+/HER2- advanced or metastatic breast cancer
RosaLEE
NIS
France
Ribociclib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 482
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced HR+/HER2- breast cancer population treated with ribociclib in France

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients by initial dose of ribociclib
timeFrame: Baseline
measure: Proportion of patients by endocrine therapy partner
timeFrame: Baseline, up to 54 months
measure: Proportion of patients for each line of treatment with ribociclib
timeFrame: Baseline
Secondary outcomes:
measure: Progression Free Survival (PFS) by treatment line and endocrine partner
timeFrame: month 12, month 24, month 36, up to 54 months
measure: Overall Survival (OS)
timeFrame: month 12, month 24, month 36, up to 54 months
measure: Identify prognostic factors influencing the OS and PFS
timeFrame: Up to 54 months
measure: Proportion of patients with adjuvant treatment and type of treatment
timeFrame: Up to 54 months
measure: Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment
timeFrame: Up to 54 months
measure: Proportion of patients by menopausal status
timeFrame: Up to 54 months
measure: Proportion of de novo metastatic patients, 1L, 2L and >2L at ribociclib initiation
timeFrame: Up to 54 months
measure: Proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown
timeFrame: Up to 54 months
measure: Overall response rate
timeFrame: Up to 54 months
measure: In the subgroup of patients with visceral metastasis: median PFS
timeFrame: Up to 54 months
measure: In the subgroup of patients with visceral metastasis: PFS rate
timeFrame: Up to 54 months
measure: In the subgroup of patients with visceral metastasis: median OS
timeFrame: Up to 54 months
measure: In the subgroup of patients with visceral metastasis: OS rate
timeFrame: Up to 54 months
measure: In the subgroup of patients with visceral metastasis: proportion of patients with CR/PR/SD/PD/unknown
timeFrame: Up to 54 months
measure: Sequential PFS (S-PFS)
timeFrame: month 12, month 24, month 36, up to 54 months
measure: Time to chemotherapy since ribociclib initiation
timeFrame: Up to 54 months
measure: Proportion of patients with ribociclib dose adjustment after treatment initiation and reason(s)
timeFrame: Up to 54 months
measure: Treatment exposure to ribociclib
timeFrame: Up to 54 months
measure: Reason(s) for discontinuation
timeFrame: Up to 54 months
measure: In the subgroup of oligometastatic patients at inclusion: proportion of patients treated with local treatment
timeFrame: Up to 54 months
measure: Proportion of visits in the site versus proportion of remote visits
timeFrame: Up to 54 months
measure: Proportion of patients with at least one hospitalization
timeFrame: Up to 54 months
measure: EuroQol 5-Dimension Questionnaire5-level version (EQ-5D-5L) scores
timeFrame: Up to 54 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Novartis Investigative Site
state: Alpes Maritimes
city: Marseille cedex 20
country: France
facility: Novartis Investigative Site
state: Bouches Du Rhone
city: Saint-Cloud
country: France
facility: Novartis Investigative Site
state: Hauts De Seine
city: Grenoble
country: France
facility: Novartis Investigative Site
state: Isere
city: Reims
country: France
facility: Novartis Investigative Site
state: Marne
city: Toulon Cedex 9
country: France
facility: Novartis Investigative Site
state: Val De Marne
city: Amiens
country: France
facility: Novartis Investigative Site
city: Argenteuil
country: France
facility: Novartis Investigative Site
city: Avignon
country: France
facility: Novartis Investigative Site
city: Bayonne
country: France
facility: Novartis Investigative Site
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Beziers
country: France
facility: Novartis Investigative Site
city: Beziers
country: France
facility: Novartis Investigative Site
city: Bobigny Cedex
country: France
facility: Novartis Investigative Site
city: Cannes
country: France
facility: Novartis Investigative Site
city: Carcassonne
country: France
facility: Novartis Investigative Site
city: Chalon sur Saone
country: France
facility: Novartis Investigative Site
city: Chambray Les Tours
country: France
facility: Novartis Investigative Site
city: Chambray Les Tours
country: France
facility: Novartis Investigative Site
city: Champigny Sur Marne
country: France
facility: Novartis Investigative Site
city: Cherbourg
country: France
facility: Novartis Investigative Site
city: Cholet
country: France
facility: Novartis Investigative Site
city: Clermont Ferrand
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand
country: France
facility: Novartis Investigative Site
city: Colmar Cedex
country: France
facility: Novartis Investigative Site
city: Compiegne
country: France
facility: Novartis Investigative Site
city: Compiegne
country: France
facility: Novartis Investigative Site
city: Corbeil Essonnes
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Dechy
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Dunkerque
country: France
facility: Novartis Investigative Site
city: Eaubonne
country: France
facility: Novartis Investigative Site
city: Frejus
country: France
facility: Novartis Investigative Site
city: Gleize
country: France
facility: Novartis Investigative Site
city: La Roche sur Yon Cedex
country: France
facility: Novartis Investigative Site
city: Libourne
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Metz
country: France
facility: Novartis Investigative Site
city: Metz
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nancy
country: France
facility: Novartis Investigative Site
city: Neuilly Sur Seine
country: France
facility: Novartis Investigative Site
city: Nimes Cedex 9
country: France
facility: Novartis Investigative Site
city: Niort
country: France
facility: Novartis Investigative Site
city: Paris 10
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Perpignan
country: France
facility: Novartis Investigative Site
city: Pierre Benite
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Pringy
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint Dizier
country: France
facility: Novartis Investigative Site
city: Saint Herblain
country: France
facility: Novartis Investigative Site
city: Saint Nazaire
country: France
facility: Novartis Investigative Site
city: Saint Pierre
country: France
facility: Novartis Investigative Site
city: Sarcelles
country: France
facility: Novartis Investigative Site
city: Soyaux
country: France
facility: Novartis Investigative Site
city: St Etienne
country: France
facility: Novartis Investigative Site
city: St Etienne
country: France
facility: Novartis Investigative Site
city: ST Malo Cedex
country: France
facility: Novartis Investigative Site
city: St Vallier
country: France
facility: Novartis Investigative Site
city: Strasbourg cedex
country: France
facility: Novartis Investigative Site
city: Suresnes
country: France
facility: Novartis Investigative Site
city: Thionville
country: France
facility: Novartis Investigative Site
city: Toulon La Seyne Sur Mer
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Valence
country: France
facility: Novartis Investigative Site
city: Valenciennes
country: France
facility: Novartis Investigative Site
city: Vandoeuvre-les-Nancy
country: France
facility: Novartis Investigative Site
city: Vantoux
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
city: Villeurbanne
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: