CTIS2022-500808-21-00进行中(未招募)1 期
Molecular PD-L1 PET/CT Imaging with 89Zr-atezolizumab to Monitor Immune Responses in metastatic Triple Negative Breast Cancer - MIMIR-mTNBC
Karolinska University Hospital0 个研究点目标入组 64 人开始时间: 2022年9月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 64
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 65+(—)
- 性别
- All
入选标准
- •Patients with metastatic triple-negative breast cancer by pathological criteria: oestrogen receptor expression <10%, progesterone receptor (PR) expression <10%, HER2 negative, on the primary tumour or a metastatic biopsy, Measurable disease according to RECIST v1.1., At least one metastatic lesion accessible for biopsy., Deemed by treating physician as fit for systemic therapy according to study protocol., ECOG performance score 0 or 1., Age >18 years old., Adequate bone marrow, renal and hepatic functions., Able and willing to provide written informed consent
排除标准
- •Contraindications for PET/CT as defined for clinical practice., Hypersensitivity to atezolizumab., Other malignancy diagnosed within the last five years., Patients in child-bearing age without adequate contraception., Pregnancy or lactation., Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders., History of autoimmune disease., Vaccination with a live vaccine within 30 days of the first dose of study treatment, A known history of HIV infection, hepatitis B or hepatitis C infection or active tuberculosis., Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomisation.
研究者
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