A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance.
The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane.
Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses.
This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important.
- Primary objective:
• to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.
-
Secondary objectives:
-
to evaluate the response rate, the time to response and the duration of response in both arms
-
to compare the disease control rate between arms
-
to evaluate the duration of disease control in both arms
-
to evaluate the overall survival in both arms
-
to evaluate safety
Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).
详细描述
RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A : iv vinflunine plus Capecitabine
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
干预措施: vinflunine (Drug)
Arm A : iv vinflunine plus Capecitabine
Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.
干预措施: Capecitabine (Drug)
capecitabineArm B : capecitabine
1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.
次要结局
未报告次要终点