Multicenter, Interventional, Single-arm, Phase IV Study Evaluating Tolerability of Eribulin and Its Relationship With a Set of Polymorphisms in an Unselected Population of Female Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy
研究概览
简要总结
On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease.
As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted.
Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.
详细描述
This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with metastatic breast cancer in relation to toxicities already described in clinical trials, and neurotoxicity in particular.
The secondary objectives of this trial include:
- To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy
- To describe treatment efficacy in terms of duration of treatment and impact on survival.
All toxicities will be collected and classified according to National Cancer Institute Common Terminology criteria for Adverse Events (NCI CTCAE) version 4.0 and monitored during all the treatment period and up to 30 days after therapy discontinuation.
In particular, evaluation of incidence and outcome of any grade AEs already recorded in previous clinical trials will be collected, as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Diagnosis of metastatic breast cancer
- •Previous treatment with anthracyclines and taxanes
- •Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication
- •Ability to comply with sample collection
- •Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
- •Absence of any contraindication to treatment
排除标准
- •Previous treatment with Eribulin in a previous line of treatment
- •Previous treatment with Eribulin off label
研究组 & 干预措施
Single arm with Eribulin mesylate
干预措施: ERIBULIN MESYLATE (Drug)
结局指标
主要结局
Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy
时间窗: Trough study completion, an average of 1 year
The association between a set of selected polymorphisms and the onset of all grades peripheral neuropathy will be investigated using blood samples collected at the time of treatment initiation.
Treatment tolerability
时间窗: Trough study completion, an average of 1 year
Treatment tolerability will also be described in terms of dose intensity and dose schedule maintenance.
OS (Overall Survival)
时间窗: Trough study completion, an average of 1 year
OS will be calculated from the date of start of therapy to the date of death.
Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade)
时间窗: Trough study completion, an average of 1 year
All toxicities and their grade will be reported according to Common Terminology criteria for Adverse Events (CTCAE) v4.0, especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.
DOT (Duration Of Treatment)
时间窗: Trough study completion, an average of 1 year
DOT will be calculated for each patient from the date of start of Eribulin treatment to the date of last Eribulin administration for any cause (i.e. progression of disease, unacceptable toxicity, patient refusal or physician decision).
次要结局
未报告次要终点