A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Clinical benefit rate for 16 weeks
研究概览
简要总结
Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast
详细描述
This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old, female
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
- •For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
- •Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
- •After Recurrence has not received cancer treatment
- •Life expectancy of at least 6 months
- •Signed and dated an informed consent form
排除标准
- •ECOG score ≧2
- •Only brain metastasis or meningeal metastasis
- •Receiving other anti-tumor treatment
- •Heart,lung,liver,kidney,bone marrow,and other functions badness
研究组 & 干预措施
TPC chemotherapy
Conventional chemotherapy(choose a):
TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin)
干预措施: TPC (Drug)
Bicalutamide
Bicalutamide 150mg/day every 28 days
干预措施: Bicalutamide 150 mg (Drug)
结局指标
主要结局
Clinical benefit rate for 16 weeks
时间窗: 16 weeks
The proportion of patients with complete response, partial response and stable disease
次要结局
- progression-free survival(24 months)
研究者
Zhong-yu Yuan
Sun Yat-sen University Cancer Center
Sun Yat-sen University