EUCTR2018-001027-40-FR进行中（未招募）1 期
ERIBRAIN - A phase II study of Eribulin in brain metastases from HER2-negative breast cancer pre-treated with anthracyclines and taxanes - ERIBRAI
Institut Paoli-Calmettes0 个研究点目标入组 95 人开始时间: 2018年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.At least 18 years of age.
- •2.Life expectancy of 3 months or longer.
- •3.ECOG performance status of 0, 1, or 2.
- •4.HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer
- •5.Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless pa-tients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease)
- •6.At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry
- •7.Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B)
- •-At least 1 measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI, OR
- •-At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two addi-tional CNS tumors measuring = 3 mm in longest diameter, for which the sum of the longest diameters is = 10 mm.
- •8.Patient with progressive disease harboring brain metastases after previous WBRT (cohort C)
- •-At least 1 measurable CNS lesion = 10 mm on T1-weighted gadolinium-enhanced MRI, OR
- •-At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two addi-tional CNS tumors measuring = 3 mm in longest diameter, for which the sum of the longest diameters is = 10 mm.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Prior therapy with eribulin.
- •2.Patients should not have had major surgery or radiotherapy (therapeutic and/or pallia-tive) within 14 days prior to initiation of study treatment, including CNS-directed radia-tion therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)
研究者
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