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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: ribociclib + ET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet all of the following criteria will be included in the RosaLEE study: Adult women aged ≥ 18 years old at inclusion. Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC. Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization. Patients having given their non-objection to participate in the study. Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics. Exclusion Criteria: Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion. Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion. Patients for whom AI or fulvestrant in monotherapy has been initiated > 28 days before inclusion. Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC. Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ribociclib + ET<br>Women prescribed ribociclib + Endocrine Therapy (ET) | Other: ribociclib + ET<br>* There is no treatment allocation. Patients administered ribociclib + endocrine Therapy (ET) by prescription will be enrolled.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HR+/HER2- advanced or metastatic breast cancer, RosaLEE, NIS, France, Ribociclib