跳至主要内容
临床试验/NCT05953909
NCT05953909进行中(未招募)不适用

Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen: A Single-Center Retrospective Study

Fujian Cancer Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月1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
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Progression free surviva (PFS)

研究概览

简要总结

A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen

详细描述

Not provided

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-
  • The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer [ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative(IHC-/+ or IHC++ and FISH/CISH-)].
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤
  • Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
  • Patients receiving eribulin-based therapy received at least two cycles of eribulin-based chemotherapy. Eribulin was treated until disease progression, unacceptable toxicity or patient refusal of treatment.
  • Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).

排除标准

  • Patients previously treated with eribulin.
  • Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
  • Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.

研究组 & 干预措施

Eribulin-Based Regimen

Not Applicable since observational study

干预措施: Eribulin-Based Regimen (Drug)

Eribulin-Based Regimen

Not Applicable since observational study

干预措施: nab-paclitaxel based regimen (Drug)

Eribulin-Based Regimen

Not Applicable since observational study

干预措施: Other Chemotherapy Regimen (Drug)

nab-paclitaxel based regimen

Not Applicable since observational study

干预措施: Eribulin-Based Regimen (Drug)

nab-paclitaxel based regimen

Not Applicable since observational study

干预措施: nab-paclitaxel based regimen (Drug)

nab-paclitaxel based regimen

Not Applicable since observational study

干预措施: Other Chemotherapy Regimen (Drug)

Other Chemotherapy Regimen

Not Applicable since observational study

干预措施: Eribulin-Based Regimen (Drug)

Other Chemotherapy Regimen

Not Applicable since observational study

干预措施: nab-paclitaxel based regimen (Drug)

Other Chemotherapy Regimen

Not Applicable since observational study

干预措施: Other Chemotherapy Regimen (Drug)

结局指标

主要结局

Progression free surviva (PFS)

时间窗: up to 24 months

The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.

Overall survival (OS)

时间窗: up to 24 months

The time interval from the date of randomization to death due to any cause.

次要结局

  • Disease Control Rate (DCR)(12 months)
  • Overall response rate (ORR)(12 months)
  • Incidence of adverse events(12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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