Breast Cancer
Conditions
Keywords
HR+/HER2- advanced or metastatic breast cancer, RosaLEE, NIS, France, Ribociclib
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.
Interventions
OTHERribociclib + ET
There is no treatment allocation. Patients administered ribociclib + endocrine Therapy (ET) by prescription will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients by initial dose of ribociclib | Baseline | Proportion of patients by initial dose of ribociclib to be collected |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| Identify prognostic factors influencing the OS and PFS | Up to 54 months | Prognostic factors influencing the OS and PFS will be listed |
| 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 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 |
| Proportion of patients by menopausal status | Up to 54 months | Proportion of patients by menopausal status (pre-/perimenopausal patients versus postmenopausal patients) |
| 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 |
| 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 |
| 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: 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| Reason(s) for discontinuation | Up to 54 months | Treatment discontinuation: permanent cessation of the treatment received, for any reason. |
| 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 |
| 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 |
| Proportion of patients with at least one hospitalization | Up to 54 months | Proportion of patients with at least one hospitalization to be collected |
| 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. |
Countries
France
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed