NL-OMON48948已完成2 期
AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial - GELATO
ederlands Kanker Instituut0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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 or aberrant staining (IHC) on a biopsy of a metastatic lesion.
- •* Estrogen receptor expression of at least 10% on a metastatic lesion (independent of progesterone receptor expression and HER2 expression)
- •* Metastatic lesion accessible for histological biopsies
- •* Evidence of progression of disease
- •* A maximum of two lines of palliative chemotherapy. Carboplatin pretreatment is allowed, as long as no progression was observed and the last dose was administered 6 months before starting study treatment
- •* 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
研究者
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