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临床试验/NCT06311383
NCT06311383已完成不适用

A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment

Novartis Pharmaceuticals252 个研究点 分布在 1 个国家目标入组 2,610 人开始时间: 2017年10月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2,610
试验地点
252
主要终点
Progression-free survival (PFS)

研究概览

简要总结

This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

详细描述

This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.

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 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status
  • No prior systemic treatment for locally advanced/metastatic disease in the palliative setting
  • The treating physician has made the decision to treat the patient
  • with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or
  • endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or
  • chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)
  • Written informed consent of the patient
  • Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study
  • Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")
  • Patient is ≥18 years

排除标准

  • Patients unable to provide written informed consent
  • Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician
  • The patient is currently under active treatment in an investigational study

研究组 & 干预措施

First-line Ribociclib + endocrine therapy

Ribociclib + letrozole, or Ribociclib + anastrozole, or Ribociclib + exemestane, or Ribociclib + fulvestrant

干预措施: First-line Ribociclib + endocrine therapy (Drug)

First-line endocrine therapy

As of physicians choice

干预措施: First-line endocrine therapy (Drug)

First-line chemotherapy

As of physicians choice

干预措施: First-line chemtherapy (Drug)

结局指标

主要结局

Progression-free survival (PFS)

时间窗: Up to 88 months

Progression-free survival was defined as first intake of study medication in current-line therapy up to first documented progress or death from any cause in this treatment line. If a patient had not had an event, progression-free survival was censored at the end of the respective therapy line.

次要结局

  • Sequential progression-free survival (PFS_S)(Up to 88 months)
  • Time to treatment failure (TTF)(Up to 88 months)
  • Time to first chemotherapy(Up to 88 months)
  • Time to next treatment / therapy (TTNT) after 1st line treatment(Up to 88 months)
  • Overall survival (OS)(Up to 88 months)
  • Dose reduction(Up to 88 months)
  • Dose interruption(Up to 88 months)
  • Discontinuations(Up to 88 months)
  • Adherence - MMAS-8 questionnaire(Up to 87 weeks)
  • Number of participants with mutations(Up to 88 months)
  • Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30(Up to 88 months)
  • Quality of life for specific cohorts and treatment lines - EORTC QLQ-BR23(Up to 88 months)
  • Quality of life for specific cohorts and treatment lines - HADS-D(Up to 88 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (252)

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