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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 17
- 主要终点
- 1.To evaluate the clinical and laboratory safety of Eribulin mesylate in treating 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
研究概览
简要总结
Eribulin is approved in India for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.This is a phase IV prospective, single arm, post marketing trial to collect AEs and efficacy data from Eribulin treated patients in daily medical practice conditions with following approved indication in India based on the DCGI approval.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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) Serum AST (SGOT) and ALT (SGPT) <3 X ULN or <5 X ULN in the presence of liver metastases Serum Creatinine <1.5 mg/dL 8.Women in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.
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
1.To evaluate the clinical and laboratory safety of Eribulin mesylate in treating 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
时间窗: six Cycles
次要结局
- To determine the objective response rate (ORR) with Eribulin in 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(Six Cycles)
研究者
研究点 (17)
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