An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Response rate as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of breast cancer. It is not yet known whether giving docetaxel together with a phytochemical is more effective than giving docetaxel alone in treating patients with breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a phytochemical works compared with giving docetaxel alone as first- or second-line therapy in treating patients with breast cancer.
详细描述
OBJECTIVES:
Primary
- To compare the response rate in HER2-negative patients with locally advanced or metastatic breast cancer or locoregional breast cancer recurrence treated with docetaxel and a dietary phytochemical vs docetaxel alone.
Secondary
- To compare the overall clinical benefit rate (i.e., objective response plus stable disease) in patients treated with these regimens.
- To compare time to progression in patients treated with these regimens.
- To compare overall survival of patients treated with these regimens.
- To assess biomarkers of response in blood samples from patients treated with these regimens.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Curcumine
With curcumin capsules
干预措施: Curcumin (Dietary Supplement)
Curcumine
With curcumin capsules
干预措施: Taxotere (Drug)
Drug taxotere only
Without curcumin
干预措施: Taxotere (Drug)
结局指标
主要结局
Response rate as assessed by RECIST criteria
时间窗: From the date of randomization until the end of the treatment, assessed up to 21 weeks
次要结局
- Overall survival as assessed by RECIST criteria(From the date of randomization until the date of death from any cause)
- Time to progression as assessed by RECIST criteria(From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 21 weeks)
- Safety as assessed by NCI CTCAE v3.0(From the date of randomization until the end of the treatment, assessed up to 21 weeks)
- Overall clinical benefit rate as assessed by RECIST criteria(From the date of randomization until the end of the treatment, assessed up to 21 weeks)