NCT00471159撤回2 期
A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Progression-free survival
研究概览
简要总结
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with confirmed advanced breast cancer.
- •Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
- •Patients with adequate general well-being, kidney and liver function.
排除标准
- •Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
- •Patients who have had prior chemotherapy for advanced breast cancer.
- •Patients of child-bearing potential who are unwilling to use contraception.
结局指标
主要结局
Progression-free survival
Tumor assessment every 6 weeks until disease progression
次要结局
- Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
- Overall Survival - Patients will be followed for survival
- Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
- Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
研究者
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