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临床试验/NCT03437083
NCT03437083已完成不适用

A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients

Eisai Korea Inc.14 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2018年1月25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
340
试验地点
14
主要终点
Progression-free survival (PFS) rate at 6 months

研究概览

简要总结

The primary objective of the study is to observe efficacy in terms of progression-free survival rate at 6 months in eribulin-treated breast cancer participants retrospectively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of locally advanced or metastatic breast cancer
  • Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016

排除标准

  • Not applicable

研究组 & 干预措施

Eribulin

Eribulin was administered at a dose of 1.4 milligrams per meters squared (mg/m^2) (as eribulin 1.23 mg/m^2) by a 2- to 5-minute intravenous infusion or as a diluted solution on Day 1 and Day 8 every 21 days.

干预措施: Eribulin mesylate (Drug)

结局指标

主要结局

Progression-free survival (PFS) rate at 6 months

时间窗: 6 months

PFS rate at 6 months is estimated based on the tumor response evaluation and is defined as the proportion of participants alive and progression-free at 6 months from the initial treatment of eribulin.

次要结局

  • Tumor response rate (TRR)(From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years))
  • PFS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years))
  • TRR in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years))
  • Progression-Free Survival (PFS)(From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years))
  • Number of participants with any treatment-emergent adverse event (TEAE)(6 months)
  • Overall Survival (OS)(From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years))
  • Time to treatment failure (TTF)(From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years))
  • OS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years))
  • PFS rate in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use(From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years))
  • OS in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use(From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years))
  • TTF in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use(From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years))
  • TRR in eribulin-treated breast cancer participants comparing early (≤third line) to late (≥ fourth line) use(From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years))
  • Number of participants with the indicated action to TEAEs(6 months)
  • Number of participants with TEAEs resulting in discontinuation of eribulin(6 months)
  • Number of participants using supportive drugs to treat AEs(6 months)
  • Median number of eribulin cycles(6 months)
  • Number of participants experiencing a dose reduction(6 months)
  • TTF in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years))
  • Mean duration of treatment(6 months)
  • Mean duration of response(6 months)
  • Mean dose intensity(6 months)
  • Number of participants with the indicated reason for treatment discontinuation(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (14)

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