NCT03264547已完成3 期
A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 2
- 主要终点
- PFS
研究概览
简要总结
To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer that is confirmed histologically or cytologically
- •Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution
- •Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics
- •>=6 months have passed since perioperative treatment with anticancer agents
- •Presence of a measurable lesion not required
- •Female aged 20-70 years old at the time of consent acquisition
- •Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of >=50%
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- •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/mm 3 (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
- •Patients planning to undergo radical surgery if they respond to a treatment
- •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
- •Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control
- •Patients who have active double cancer
- •Patients who have poorly controlled hypertension, or unstable angina
- •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
- •Patients with a past history of myocardial infarction within 6 months before enrollment
- •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
- •Patients with interstitial pneumonia which is symptomatic or requires treatment
- •Pregnant women, those with a positive pregnancy test, and lactating women
- •Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive
- •Patients with hypersensitivity against pertuzumab and trastuzumab
- •Patients whom the investigator consider unable or unwilling to follow the protocol requirements
研究组 & 干预措施
Arm A
Active Comparator
Trastuzumab + pertuzumab + Taxane*
*Taxane is chosen from the following; Docetaxel or Paclitaxel
干预措施: Docetaxel (Drug)
Arm A
Active Comparator
Trastuzumab + pertuzumab + Taxane*
*Taxane is chosen from the following; Docetaxel or Paclitaxel
干预措施: Pertuzumab (Drug)
Arm A
Active Comparator
Trastuzumab + pertuzumab + Taxane*
*Taxane is chosen from the following; Docetaxel or Paclitaxel
干预措施: Trastuzumab (Drug)
Arm A
Active Comparator
Trastuzumab + pertuzumab + Taxane*
*Taxane is chosen from the following; Docetaxel or Paclitaxel
干预措施: Paclitaxel (Drug)
Arm B
Experimental
Trastuzumab+ Pertuzumab + Eribulin
干预措施: Pertuzumab (Drug)
Arm B
Experimental
Trastuzumab+ Pertuzumab + Eribulin
干预措施: Trastuzumab (Drug)
Arm B
Experimental
Trastuzumab+ Pertuzumab + Eribulin
干预措施: Eribulin (Drug)
结局指标
主要结局
PFS
时间窗: 5.75 years
Progression-free survival
次要结局
- RR(5.75 years)
- DR(5.75 years)
- PRO(5.75 years)
- Safety(5.75 years)
- Biomaker(5.75 years)
- nMFS(5.75 years)
- TTF of the subsequent treatment(5.75 years)
- OS(6.25 years)
研究者
研究点 (2)
Loading locations...
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