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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,019
- 试验地点
- 83
- 主要终点
- Proportion of patients by endocrine therapy partner
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ribociclib + ET
Women prescribed ribociclib + Endocrine Therapy (ET)
干预措施: ribociclib + ET (Other)
结局指标
主要结局
Proportion of patients by endocrine therapy partner
时间窗: 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
时间窗: 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
时间窗: Baseline
Proportion of patients by initial dose of ribociclib to be collected
次要结局
- Proportion of patients treated with chemotherapy/ET/targeted therapy and type of local treatment(Up to 54 months)
- In the subgroup of patients with visceral metastasis: median PFS(Up to 54 months)
- In the subgroup of patients with visceral metastasis: PFS rate(Up to 54 months)
- In the subgroup of patients with visceral metastasis: median OS(Up to 54 months)
- Identify prognostic factors influencing the OS and PFS(Up to 54 months)
- Proportion of de novo metastatic patients, 1L, 2L and >2L at ribociclib initiation(Up to 54 months)
- Progression Free Survival (PFS) by treatment line and endocrine partner(month 12, month 24, month 36, up to 54 months)
- Overall Survival (OS)(month 12, month 24, month 36, up to 54 months)
- Time to chemotherapy since ribociclib initiation(Up to 54 months)
- Proportion of patients with ribociclib dose adjustment after treatment initiation and reason(s)(Up to 54 months)
- Treatment exposure to ribociclib(Up to 54 months)
- EuroQol 5-Dimension Questionnaire5-level version (EQ-5D-5L) scores(Up to 54 months)
- In the subgroup of patients with visceral metastasis: proportion of patients with CR/PR/SD/PD/unknown(Up to 54 months)
- Reason(s) for discontinuation(Up to 54 months)
- Proportion of patients with complete response (CR)/partial response (PR)/stable disease (SD)/progressive disease (PD)/unknown(Up to 54 months)
- Sequential PFS (S-PFS)(month 12, month 24, month 36, up to 54 months)
- Proportion of patients with at least one hospitalization(Up to 54 months)
- Proportion of patients with adjuvant treatment and type of treatment(Up to 54 months)
- Proportion of patients by menopausal status(Up to 54 months)
- In the subgroup of oligometastatic patients at inclusion: proportion of patients treated with local treatment(Up to 54 months)
- Overall response rate(Up to 54 months)
- In the subgroup of patients with visceral metastasis: OS rate(Up to 54 months)
- Proportion of visits in the site versus proportion of remote visits(Up to 54 months)