NCT03147040终止2 期
AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Number of patients free of progression at 6 months
研究概览
简要总结
This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC
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
- •Signed and written informed consent
- •Age 18 year or older
- •Metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and E-cadherin loss on a biopsy of a metastatic lesion.
- •Metastatic lesion accessible for histological biopsies
- •Evidence of progression of disease
- •A maximum of two lines of palliative chemotherapy
- •WHO performance status of 0 or 1
- •Evaluable disease or measurable according to RECIST 1.1
排除标准
- •Leptomeningeal disease localization
- •History of having received other anticancer therapies within 2 weeks of start of the study drug
- •History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression
- •Prior treatment with immune checkpoint blockade
- •Live vaccine within 2 weeks prior to start of study
- •Active other cancer
- •Active hepatitis B
研究组 & 干预措施
Carboplatin/Atezolizumab
Experimental
Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin
干预措施: Carboplatin (Drug)
Carboplatin/Atezolizumab
Experimental
Carboplatin AUC=1.5, weekly schedule, maximum 12 administrations Atezolizumab, 1200 mg flat dose, 3-weekly schedule, starting after two administrations of carboplatin
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Number of patients free of progression at 6 months
时间窗: At 6 months
Progression as defined by RECST 1.1
次要结局
- Number of patients free of progression at 6 months in the IR profile subgroup(At 6 months)
- Number of patients free of progression at 6 months in the non- IR profile subgroup(At 6 months)
- Number of patients free of progression at 12 months(At 12 months)
- Objective Response Rate(Assessed up to 60 months)
- Overall Survival(Assessed up to 60 months)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(Assessed up to one month after end of treatment)
研究者
研究点 (4)
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