NCT01908101已完成2 期
Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 12
- 主要终点
- PFS
研究概览
简要总结
This phase II trial studies how well eribulin mesylate works in treating patients with previously treated breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
详细描述
PRIMARY OBJECTIVES:
I. Progression free survival (PFS).
SECONDARY OBJECTIVES:
I. Frequency of alopecia with absence or decrease to < 50%.
II. Incidence of grade 3 and 4 neutropenia of < 30%.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent
- •Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
- •At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- •At least one non lymph node lesion of >= 1.0 cm or lymph node >= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
- •Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
- •Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions < 10 mm or lymph nodes < 15 mm in short axis) with rising serum CA15-3 or CA 27.29 or CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration. The second CA 15-3 or CA 27.29 value must have at least a 20% increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
- •Absolute neutrophil count >= 1,500/mm^3
- •Hemoglobin >= 10 g/dL
- •Platelets >= 100,000/mm^3
- •Creatinine =< 1.5 x upper limit of normal (ULN)
- •Total bilirubin =< 1.5 x ULN
- •Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)
- •Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
- •Life expectancy of > 12 weeks
排除标准
- •Prior treatment with eribulin
- •Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:
- •Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors
- •Denosumab or bisphosphonates to treat metastatic bone disease
- •Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
- •Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy
- •Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- •Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment
- •Radiotherapy within 14 days of study treatment
- •Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
- •Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
- •Patients with peripheral neuropathy > grade 2 regardless of etiology
- •Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)
- •Concomitant severe or uncontrolled medical disease
- •Significant psychiatric or neurologic disorder which would compromise participation in the study
- •Pregnant or breast-feeding females
研究组 & 干预措施
Treatment (eribulin mesylate)
Experimental
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Eribulin Mesylate (Drug)
Treatment (eribulin mesylate)
Experimental
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
PFS
时间窗: From study enrollment until the earliest date of disease progression or death, assessed up to 1 year
Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.
次要结局
未报告次要终点
研究者
研究点 (12)
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