A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 30
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.
详细描述
This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.
If a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.
Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
- •No prior chemotherapy regimen for metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
- •The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit
- •The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
排除标准
- •Hypersensitivity to docetaxel or polysorbate 80
- •Neuropathy ≥ Grade 2 at the Baseline Visit
- •Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
- •The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody
研究组 & 干预措施
A. YM155 plus docetaxel
干预措施: YM155 (Drug)
A. YM155 plus docetaxel
干预措施: Docetaxel (Drug)
B. docetaxel alone
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: At the time of progression or death or at 2 year follow up
次要结局
- Duration of response(At the time of progression or at 2 year follow up)
- Time to response(At the time of response or at 2 year follow up)
- Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)(Up to 30 days after last subject discontinues treatment)
- Overall survival(At the time of death or at 2 year follow up)
- Objective response rate (proportion of subjects with complete response or partial response)(At the time of progression or death or at 2 year follow up)
- Clinical benefit rate(At the time of progression or death or at 2 year follow up)