A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
研究概览
简要总结
The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
详细描述
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged >=18 years
- •WHO (ECOG) performance status 0-2
- •Estimated life expectancy of >=3 months
- •Have given written informed consent and are available for prolonged follow-up
排除标准
- •Patients with previous chemotherapy for recurrent breast cancer
- •Breast cancer recurrence within 12 months after taxane treatment
- •Her-2/neu expression
- •Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- •Brain metastasis
- •uncontrolled infection, medically uncontrollable heart disease
- •other serious medical illness or prior malignancies
- •Pregnant or lactating women were excluded.
研究组 & 干预措施
Genexol-PM
All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion)
- Spiral CT : lesion ≥ 10mm (unidimension)
- X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)
干预措施: Paclitaxel loaded Polymeric micelle (Drug)
结局指标
主要结局
Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
时间窗: 1 year
次要结局
- Tumor control rate(1 year)
- Toxicity(1 year)
- Progression Free Survival(1 year)