JPRN-UMIN000030242已完成2 期
Phase II study of nivolumab + bevacizumab + paclitaxel in patients with HER2-negative metastatic breast cancer Nivolumab Evaluation With BEvacizumab And pacliTaxel (NEWBEAT) study (WJOG9917B) - Phase II study of nivolumab combination therapy for HER2-negative metastatic breast cancer (WJOG9917B)- NEWBEAT study
Coordinating committee for WJOG 9917B investigator-initiated clinical study0 个研究点目标入组 57 人开始时间: 2017年12月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
研究概览
简要总结
For patients with HER2-negative metastatic breast cancer, nivolumab plus bevacizumab and paclitaxel combination therapy showed the promising efficacy and toxicities were manageable.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1)Patients treated with drug therapy targeting anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies or other T-cell co-stimulatory receptors. 2)Patients with a history of infiltrative malignancies within the last 5 years. 3)Patients received taxane chemotherapy within the last 6 months. 4)Patients with metastases to bone only. 5)Patients received molecular targeted therapy or radiotherapy within 14 days before enrollment. 6)Patients received another investigational treatment within 28 days before enrollment. 7)Patients received a live vaccine within 30 days before the first dose of the study drug. 8)Patients required treatment with systemic corticosteroids at a predonine equivalent dose of > 10mg/day or immunosuppressive drugs for active autoimmune disease within 28 days prior to enrollment. 9)Patients with active infection requiring systemic treatment. 10)Patients with concurrent interstitial lung disease/pneumonitis or a history of interstitial lung disease/pneumonitis requiring treatment with systemic corticosteroids. 11)Patients who are pregnant or possibly pregnant or breastfeeding. 12)Patients with HBs antigen-positive or HCV antibody-positive. 13)Patients who are either HIV-1 or HIV-2 antibody-positive. 14)Patients with major cardiovascular disease. Patients with myocardial infarction or acute coronary artery disease, or underwent coronary angioplasty, stenting or bypass surgery within the last 6 months. Patients with NYHA class III to IV congestive heart failure. 15)History of disease or underlying condition: - uncontrolled diabetes - peripheral neuropathy (Grade=>2) - congenital bleeding diathesis or coagulation disorders - arterial thrombosis or venous thrombosis before 6 months from the enrollment - gastrointestinal tract perforation - active peptic ulcer disease or bleeding (Grade =>3) - other serious conditions such as renal failure or liver failure
研究者
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