Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai GmbH
- 入组人数
- 353
- 试验地点
- 4
- 主要终点
- Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0
研究概览
简要总结
Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (MBC) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Locally advanced or MBC with progression after at least one chemotherapeutic regimen for advanced disease eligible for treatment with eribulin according to Fachinformation. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless participants were not suitable for these treatments
- •1-3 prior chemotherapeutic regimens for advanced disease
- •Age >=18 years at the time of Informed Consent
- •Ability to understand and willingness to respond to questions related to their health
- •Decision for the participant to start treatment with eribulin has been made prior to inclusion in this study.
- •Signed written Informed Consent
排除标准
- •Previous treatment with eribulin in any line of treatment
- •Contraindication according to the Fachinformation of eribulin
- •Pregnancy or lactation
- •Participation in an interventional clinical trial at the same time
研究组 & 干预措施
Eribulin-treated participants
Participants treated with eribulin according to Fachinformation and managed according to clinical practice
干预措施: Eribulin (Drug)
结局指标
主要结局
Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants experiencing eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to eribulin treatment discontinuation due to eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to resolution of eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0.
Number of resolved cases in participants who experience eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Percentage of resolved cases in participants who experience eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN
时间窗: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
次要结局
- Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire(Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first)
- Time to disease progression(Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first)
- Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire(Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first)
- Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE(Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first)
- Percentage of participants with any SAE and percentage of participants with any non-serious AE(Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first)