JPRN-UMIN000009612已完成1 期
Phase I Clinical Study of Combination Therapy with Eribulin and Gemcitabine in Patients with Progressive Recurring Breast Cancer (JBCRG-18Gem) - JBCRG-18Gem
JBCRG (Japan Breast Cancer Research Group)0 个研究点目标入组 7 人开始时间: 2012年12月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
Results Grade 3 or higher hematological toxicities, including neutropenia, frequently occurred, it was difficult to conduct this combination therapy as scheduled. Drug-drug interactions between ERI and GEM were not observed. Conclusions The combination therapy with ERI and GEM is tolerated in patients with metastatic breast cancer, and it is crucial to manage hematological toxicities that frequently occur.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) Patients with coexisting infection or cases with pyrexia suspected of infection. 2) Cases with serious drug allergy. 3) Cases with serious renal disorder and hepatic disorder (jaundice). 4) Cases with clear indications of interstitial pneumonia or pulmonary fibrosis in chest X-ray. 5) Cases with large pleural/peritoneal effusion (patients required drainage) 6) Cases with poorly-controlled hypertension and diabetes mellitus. 7) Cases with continuous systemic administration (oral or intravenous) of steroid. 8) Pregnant patients or cases with possible pregnancy. 9) Patients with active multiple primary cancer. 10) Cases with preexisting condition of psychiatric disorder or central nervous system disorder. 11) Cases with active brain metastasis. 12) Cases participating in other clinical study. 13) Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study. 14) Patients with hepatitis B antibody.
研究者
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