NL-OMON47543招募中2 期
Adaptive phase II randomized non-comparative trial of nivolumab after induction treatment in triple-negative breast cancer (TNBC) patients: TONIC-trial - TONIC
ederlands Kanker Instituut0 个研究点目标入组 84 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
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 99（—）
入选标准
- •- metastatic ER and HER2 negative breast cancer
- •- 18 years or older
- •- metastatic lesions accessible for histological biopsy
- •- maximum of three lines of chemotherapy for metastatic disease
- •- measurable or evaluable disease according to RECIST 1.1
- •- disease free interval (defined as time between first diagnosis or local
- •recurrence and first metastasis) longer than 1 year
- •- WHO performance status 0 or 1
- •- Subjects with brain metastases are eligible if these have been treated and
- •there is no magnetic resonance imaging (MRI) evidence of progression for at
- •least 4 weeks after treatment is completed and prior to first dose of study
- •drug administration. There must also be no requirement for immunosuppressive
- •doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at
- •least 2 weeks prior to study drug administration
- •- Signed written informed consent
排除标准
- •- known leptomenigeal disease localization- history of having recceived other
- •anticancer therapies within 2 weeks of start of the study drug
- •- history of immunodeficiency, autoimmune disease, conditions requiring
- •immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections
- •- prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4
- •- current pregnancy or breastfeeding
研究者
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