CTRI/2018/03/012349
已完成
4 期
Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients with Locally Advanced or Metastatic Breast Cancer
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: null- Patients with locally advanced or metastatic breast cancer, who have progressed after at least one regimens of chemotherapy which has included anthracycline and taxane therapy
- 发起方
- Eisai Pharmaceuticals India Private Limited
- 入组人数
- 200
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Females of 18 years of age or older.
- •2\.Patients willing to give informed written consent.
- •3\.Patients with locally advanced or metastatic breast cancer.
- •4\.Patients must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless patients who are not suitable for these treatments.
- •5\.Patients must have documented disease progression within or on 6 months from their last anti\-cancer therapy.
- •6\.ECOG performance status \=2
- •7\.Patients must have normal organ and marrow function as defined below:Absolute neutrophil count \>1,500/mcl
- •Hemoglobin \>10\.0 g/dL
- •Platelets \>100,000/mcL
- •Serum total bilirubin \<1\.5 X upper limit of normal (ULN)
排除标准
- •1\.Pregnant and lactating females
- •2\.Hypersensitivity to the active substance or any of the excipients
- •3\.Patients who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start
- •4\.Participants receiving any other investigational agents
结局指标
主要结局
未指定
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