An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Phase I: Number of Participants with a Dose-Limiting Toxicity
研究概览
简要总结
This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •women >=18 years;
- •locally advanced or metastatic breast cancer;
- •HER-2 overexpression (FISH + or IHC 3+);
- •>=1 measurable lesion;
- •up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.
排除标准
- •pre-existing neuropathy >=grade 2;
- •known CNS metastases;
- •congestive heart failure, or myocardial infarction within the last 6 months;
- •previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
研究组 & 干预措施
Phase I - Epothilone D Dose Escalation
干预措施: Epothilone D (Drug)
Phase I - Epothilone D Dose Escalation
干预措施: Herceptin (Drug)
Phase II - Epothilone D Maximum Tolerated Dose
干预措施: Epothilone D (Drug)
Phase II - Epothilone D Maximum Tolerated Dose
干预措施: Herceptin (Drug)
结局指标
主要结局
Phase I: Number of Participants with a Dose-Limiting Toxicity
时间窗: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Phase II: Objective Response Rate (per RECIST criteria)
时间窗: From first dose of study treatment until documented response (up to 3 years, 2 months)
次要结局
- Phase II: Duration of Response(From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months))
- Phase II: Time to Tumor Progression(From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months))
- Phase I: Plasma Concentration of Epothilone D at Specified Timepoints(Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days))
- Number of Participants with at Least One Adverse Event(From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months))