JPRN-jRCTs021180027进行中（未招募）3 期
A phase III clinical study to compare the combination therapy of eribulin mesylate + trastuzumab + pertuzumab with paclitaxel or Docetaxel + trastuzumab + pertuzumab - JBCRG-M06(EMERALD)
Yamashita Toshinari0 个研究点目标入组 480 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
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
- >= 20age old 至 <= 70age old（—）
- 性别
- Female
入选标准
- •1)Patients with breast cancer that is confirmed histologically or cytologically
- •2)Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution
- •3)Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics
- •4) >=6 months have passed since perioperative treatment with anticancer agents
- •5)The patient must have an evaluable lesion. (Measurable lesions are not necessary, but lesions that can confirm progress are essential)
- •6)Female aged 20-70 years old at the time of consent acquisition
- •7)Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of >=50%
- •8)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- •9)Patients who have maintained major organ functions, meeting all of the following criteria on a test within 28 days before enrollment. If there are multiple test results during this period, that obtained immediately before enrollment should be adopted.
- •(1)Neutrophil count: >=1,500/mm3
- •(2)Platelet count: >=100,000/mm3
- •(3)Hemoglobin: >=9.0 g/dL
- •(4)Total bilirubin: <=1.5 mg/dL
- •(5)AST (GOT), ALT (GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis)
- •(6)Serum creatinine: <=1.5 mg/dL
- •10)Patients with a life expectancy of at least 6 months
- •11)Patient who submits written consent herself after receiving sufficient explanation about this study
- •12)Patients who can undergo QOL investigation
排除标准
- •1)Patients planning to undergo radical surgery if they respond to a treatment
- •2)Patients who have non-hematological adverse events assessed as Grade >=3 in the Common Terminology Criteria for Adverse Events ver. 4.0 in the Japanese JCOG version (CTCAE v4.0-JCOG) at the time of enrollment
- •3)Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control
- •4)Patients who have active double cancer
- •5)Patients who have poorly controlled hypertension, or unstable angina
- •6)Patients who have a past history of congestive heart failure assessed as Class ll or higher in the New York Heart Association (NYHA) classification, or clinically significant arrhythmia requiring treatment
- •7)Patients with a past history of myocardial infarction within 6 months before enrollment
- •8)Patients who are expected to undergo major surgical treatment or who had severe injury within 28 days before enrollment, or who require major surgical treatment during the study treatment period
- •9)Patients with interstitial pneumonia which is symptomatic or requires treatment
- •10)Pregnant women, those with a positive pregnancy test, and lactating women
- •11)Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive
- •12)Patients with hypersensitivity against pertuzumab and trastuzumab
- •13)Patients whom the investigator consider unable or unwilling to follow the protocol requirements
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