A Multicenter, Open-label Phase I/II Trial of the Safety and Efficacy of the dHER2 Recombinant Protein Combined With Immunological Adjuvant AS15 in Patients With Metastatic Breast Cancer Overexpressing HER2/Neu
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 15
- 主要终点
- Vaccine-related Grade 3 or 4 toxicity (other than skin toxicity and influenza-like symptoms) according to the Common Terminology Criteria for Adverse Events version 3.0
研究概览
简要总结
Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.
详细描述
This Phase I/II study will be conducted according to a multicenter, open-label design. At least 20 patients will receive the vaccine as first-line and at least 20 as second-line treatment. The treatment will comprise a maximum of 18 injections of dHER2 vaccine. Follow-up phase: This will commence with the end-of-treatment examination, followed by examinations three months, six months and twelve months after the last study vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Vaccine-related Grade 3 or 4 toxicity (other than skin toxicity and influenza-like symptoms) according to the Common Terminology Criteria for Adverse Events version 3.0
时间窗: During the study.
Objective clinical response (CR or PR)
时间窗: At each tumor evaluation (Visits 7, 14 and 21)
次要结局
- Functional activity in vitro(At all point during treatment (as specified in the study schedule))
- Adverse events related to potential cardiotoxicity(Throughout the study)
- Unsolicited adverse events (serious and non-serious)(At any time during the study)
- Laboratory values: hematological and biochemical variables (including coagulation).(at all point during treatment as specified in the study schedule)
- Mixed response(At each tumor evaluation (Visits 7, 14 and 21))
- Electrocardiographic results(at the end of cycle 1 and cycle 2 and at first follow-up visit)
- Stable disease(At each tumor evaluation (Visits 7, 14 and 21))
- Time to disease progression(At the time of analysis.)
- Anti-dHER2, anti-HER2 ECD and anti-HER2 ICD seropositivity.(At all point during treatment (as specified in the study schedule))
- Frequency of cellular immune response in vitro to dHER2, HER2 ECD and HER2 ICD(At all point during treatment (as specified in the study schedule))
- Any documented toxicity(At any time during the study)
- Time to onset of response, defined as time from first vaccination to the initial response(At the time of analysis.)
- The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented(At the time of analysis.)
- Adverse events of Grades 3 and 4(Throughout the study)
- Solicited local and general signs and symptoms (recorded by the patients on diary cards)(During a period of four days following each administration of study vaccine)
- Unsolicited serious adverse events(At any time during the study)
- Left ventricular ejection fraction(At screening and at appropriate intervals during treatment.)
- Vital signs.(at each administration)
- Results of physical examination(At each visit)