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

N/AActive Not RecruitingNCT05697146

Novartis Pharmaceuticals1,019 enrolled

Overview

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.

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

1,019

Conditions

Breast Cancer

Interventions

ribociclib + ETOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (82)

Outcomes

Primary Outcomes

Proportion of patients by initial dose of ribociclib

Proportion of patients by initial dose of ribociclib to be collected

Time frame: 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)

Time frame: 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

Time frame: Baseline

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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

Time frame: Up to 54 months

Data from ClinicalTrials.gov

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Novartis Investigative Site

Nice, Alpes Maritimes, France

Novartis Investigative Site

Marseille, Bouches Du Rhone, France

Novartis Investigative Site

Dijon, Cote D Or, France

Novartis Investigative Site

Saint-Denis, France, France

Novartis Investigative Site

Valenciennes, France, France

Novartis Investigative Site

Saint-Cloud, Hauts De Seine, France

Novartis Investigative Site

Grenoble, Isere, France

Novartis Investigative Site

Reims, Marne, France

Novartis Investigative Site

Toulon, Val De Marne, France

Novartis Investigative Site

Amiens, France

...and 72 more locations

Proportion of patients with adjuvant treatment and type of treatment

Proportion of patients with adjuvant treatment and type of treatment to be collected

Time frame: 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

Time frame: Up to 54 months

Proportion of patients by menopausal status

Proportion of patients by menopausal status (pre-/perimenopausal patients versus postmenopausal patients)

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Up to 54 months

In the subgroup of patients with visceral metastasis: median PFS

Time frame: Up to 54 months

In the subgroup of patients with visceral metastasis: PFS rate

Time frame: Up to 54 months

In the subgroup of patients with visceral metastasis: median OS

Time frame: Up to 54 months

In the subgroup of patients with visceral metastasis: OS rate

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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).

Time frame: Up to 54 months

Treatment exposure to ribociclib

Treatment exposure to ribociclib: time from treatment initiation to treatment discontinuation.

Time frame: Up to 54 months

Reason(s) for discontinuation

Treatment discontinuation: permanent cessation of the treatment received, for any reason.

Time frame: 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

Time frame: 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

Time frame: Up to 54 months

Proportion of patients with at least one hospitalization

Proportion of patients with at least one hospitalization to be collected

Time frame: 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.

Time frame: Up to 54 months