Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
研究概览
简要总结
Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.
详细描述
Primary Objectives:
To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate.
Secondary Objective(s):
- Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population.
2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate.
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
- •Female with histologically confirmed breast cancer.
- •Patients must have evidence of metastatic disease (non measurable disease is eligible).
- •Radiologically confirmed metastatic brain lesion by MRI.
- •Brain metastases from breast cancer with or without prior WBRT, STS of surgical resection. Progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT.
- •Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment.
- •No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months.
- •Patients may not be on any cytotoxic chemotherapy or hormonal treatment for breast cancer during protocol treatment. Trastuzumab is allowed in HER2 positive patients).
- •Able to comprehend and willing to sign an Informed Consent Form (ICF)
- •Karnofsky performance status ≥ 60
- •No brain radiation therapy > 4 weeks
- •No chemotherapy for > 3 weeks before planned start of protocol treatment
- •Adequate bone marrow, renal, and hepatic function, per local reference laboratory ranges as follows:
- •Absolute neutrophil count (ANC) ≥ 1,500/mm3
- •Platelet count ≥ 100,000/mm3
- •Hemoglobin ≥ 9 g/dL
- •Calculated creatinine clearance (CrCl) ≥ 30mL/min (Cockcroft-Gault method)
- •Patients with normal, mild or moderate hepatic dysfunction are eligible.
- •Calcium <10.1 mg/dL (corrected to serum albumin as follows: Corrected Calcium = (0.8 x (4 - patient albumin)) + serum Ca
- •Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
- •Able to undergo MRI evaluation with and without gadolinium contrast
排除标准
- •Patients with the presence of an active infection, abscess or fistula
- •Known leptomeningeal disease or CNS midline shifts.
- •Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.
- •Severe conduction abnormality including significant QTc prolongation >450ms.
- •Patients with grade 3/4 peripheral neuropathy.
- •Patients with pacemaker or an ICD devices.
- •Previous treatment with eribulin mesylate.
研究组 & 干预措施
Eribulin Mesylate
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
干预措施: Eribulin Mesylate (Drug)
Eribulin Mesylate
The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
干预措施: MRI (Device)
结局指标
主要结局
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
时间窗: At 12 weeks
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
次要结局
- Objective Response Rate (RR)(up to 2 years from start of treatment)
- Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events(up to 2 years from start of treatment)
- Median Duration of CNS Response(up to 2 years from start of treatment)
- Systemic Disease Response Rate(up to 2 years from start of treatment)
- Median Overall Survival (OS)(up to 2 years from start of treatment)
- Number of Patients With CBR(At 12 weeks)