Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.
详细描述
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •To be included in this study, you must meet the following criteria:
- •Metastatic breast cancer confirmed by biopsy
- •No more than one prior chemotherapy regimen for metastatic breast cancer
- •Able to perform activities of daily living with minimal assistance
- •Adequate bone marrow, liver and kidney function
- •Age 18 years or older
- •Give written informed consent
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Moderate to severe peripheral neuropathy
- •Uncontrolled blood pressure or uncontrolled heart beat irregularities
- •Diabetes Mellitus with fasting blood sugar greater than 200 mg %
- •Significant heart disease within the prior 6 months
- •Severe or uncontrolled medical disease
- •Active uncontrolled infection
- •Known chronic liver disease
- •Known diagnosis of HIV infection
- •Pregnant or breast feeding females
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
研究组 & 干预措施
Intervention
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
干预措施: Imatinib (Drug)
Intervention
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 18 months
Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.
次要结局
- Overall Survival (OS)(18 months)
- Progression Free Survival (PFS)(18 months)