Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants with locally advanced or metastatic breast cancer.
- •Participants 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 participants who are not suitable for these treatments.
- •Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=)
- •Participants must have normal organ and marrow function as defined below:
- •Absolute neutrophil count greater than (>) 1,500 per microliter (/mcL)
- •Hemoglobin >10.0 gram per deciliter (g/dL)
- •Platelets >100,000/mcl
- •Serum total bilirubin less than (<) 1.5*upper limit of normal (ULN)
- •Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase [SGPT]) <3*ULN or <5*ULN in the presence of liver metastases
- •Serum creatinine <1.5 mg/dL.
- •Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.
排除标准
- •Hypersensitivity to the active substance or any of the excipients.
- •Participants 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.
- •Participants receiving any other investigational agents.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
- •Participants requiring concurrent anti-cancer therapy during the study period.
- •Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.
研究组 & 干预措施
Eribulin Mesylate 1.23 mg
Participants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles.
干预措施: Eribulin Mesylate (Drug)
结局指标
主要结局
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Clinical Safety will be assessed by recording the adverse events (AEs) and serious AEs (SAEs) observed during the study period and its relation to the study medication. AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect.
Number of Participants with TEAEs Related to Laboratory Parameters
时间窗: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.
次要结局
- Objective Tumor Response(Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months))
- Objective Response Rate (ORR)(Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months))