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

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: ribociclib + ET

• Registration Number: NCT05697146
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2022-11-08
• Study Start: 2022-12-13
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-03-25
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 482

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ribociclib + ET	ribociclib + ET	Women prescribed ribociclib + Endocrine Therapy (ET)

Primary Outcome Measures

Name	Time	Method
Proportion of patients by endocrine therapy partner	Baseline, up to 54 months	Proportion of patients by endocrine therapy partner to be collected(e.g., tamoxifen, letrozole, fulvestrant, anastrozole, exemestane, LHRH agonist)
Proportion of patients for each line of treatment with ribociclib	Baseline	Proportion of patients for each line of treatment with ribociclib (1L, 2L, \>2L) to be collected
Proportion of patients by initial dose of ribociclib	Baseline	Proportion of patients by initial dose of ribociclib to be collected

Secondary Outcome Measures

Name	Time	Method
Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment	Up to 54 months	Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment to be collected
In the subgroup of patients with visceral metastasis: median PFS	Up to 54 months	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).
In the subgroup of patients with visceral metastasis: PFS rate	Up to 54 months	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).
In the subgroup of patients with visceral metastasis: median OS	Up to 54 months	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.
Identify prognostic factors influencing the OS and PFS	Up to 54 months	Prognostic factors influencing the OS and PFS will be listed
Progression Free Survival (PFS) by treatment line and endocrine partner	month 12, month 24, month 36, up to 54 months	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).
Proportion of de novo metastatic patients, 1L, 2L and >2L at ribociclib initiation	Up to 54 months	Proportion of de novo metastatic patients, 1L, 2L and \>2L at ribociclib initiation to be collected
Overall Survival (OS)	month 12, month 24, month 36, up to 54 months	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.
Time to chemotherapy since ribociclib initiation	Up to 54 months	Time to chemotherapy since ribociclib initiation to be collected
Proportion of patients with ribociclib dose adjustment after treatment initiation and reason(s)	Up to 54 months	Proportion of patients with ribociclib dose adjustment after treatment initiation; adjustment type (dose modifications/interruptions during treatment) and reason(s) for dose modifications/interruptions).
Treatment exposure to ribociclib	Up to 54 months	Treatment exposure to ribociclib: time from treatment initiation to treatment discontinuation.
EuroQol 5-Dimension Questionnaire5-level version (EQ-5D-5L) scores	Up to 54 months	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.
In the subgroup of patients with visceral metastasis: proportion of patients with CR/PR/SD/PD/unknown	Up to 54 months	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
Reason(s) for discontinuation	Up to 54 months	Treatment discontinuation: permanent cessation of the treatment received, for any reason.
Proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown	Up to 54 months	Proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown to be collected
Sequential PFS (S-PFS)	month 12, month 24, month 36, up to 54 months	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.
Proportion of patients with at least one hospitalization	Up to 54 months	Proportion of patients with at least one hospitalization to be collected
Proportion of patients with adjuvant treatment and type of treatment	Up to 54 months	Proportion of patients with adjuvant treatment and type of treatment to be collected
Proportion of patients by menopausal status	Up to 54 months	Proportion of patients by menopausal status (pre-/perimenopausal patients versus postmenopausal patients)
In the subgroup of oligometastatic patients at inclusion: proportion of patients treated with local treatment	Up to 54 months	In the subgroup of oligometastatic patients at inclusion: proportion of patients treated with local treatment and treatment outcome to be collected
Overall response rate	Up to 54 months	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.
In the subgroup of patients with visceral metastasis: OS rate	Up to 54 months	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.
Proportion of visits in the site versus proportion of remote visits	Up to 54 months	Proportion of visits in the site versus proportion of remote visits to be collected

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Villeurbanne, France