Phase Ib/II study to assess efficacy, safety & immunological biomarker of anti PD-1 antibody with radiation therapy in patients with HER-2-negative metastatic breast cancer - Phase Ib/II study to assess efficacy, safety & immunological biomarker of anti PD-1 antibody with radiation therapy in patients with HER-2-negative metastatic breast cancer(KBCRN-B-002

General Incorporated Association Kyoto Breast Cancer Research Network0 个研究点目标入组 32 人开始时间: 2017年2月8日最近更新: 2024年5月27日

适应症

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•1) Patients who have neuropathy (more than Grade 2) 2) Patients with any active autoimmune disease or a history of known autoimmune disease. 3) Patients who has a history of pneumonitis or interstitial lung disease. 4) Active, untreated central nervous system metastasis. 5) Patients with pericardial effusion, pleural effusion or ascites requiring treatment 6) Patients with uncontrolled diabetes mellitus 7) Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment. 8) Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment. 9) Pregnant or breast-feeding women. 10) Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 11) Patients considered ineligible for participation in this study by their attending physicians

发起方

General Incorporated Association Kyoto Breast Cancer Research Network