Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 116
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.
详细描述
OBJECTIVES:
- Compare the progression-free survival of patients with stage IV bone metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of dasatinib.
- Compare the response rate (complete and partial, confirmed and unconfirmed) in patients treated with these regimens.
- Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with these regimens.
- Compare the circulating tumor cell response rate in patients treated with these regimens.
- Compare the anti-osteoclast activity, as measured by changes in bone turnover markers, in patients treated with these regimens.
- Compare the frequency and severity of toxicities of these regimens in these patients.
- Compare the pain profiles of these patients and explore changes over time.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dasatinib once daily.
- Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers.
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
- 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
Arm I
Patients receive oral dasatinib once daily.
干预措施: dasatinib (Drug)
Arm II
Patients receive oral dasatinib twice daily.
干预措施: dasatinib (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Up to 2 years
RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
次要结局
- Circulating Tumor Cells (CTC) Response Rate(Up to 4 weeks)
- Change in Serum Bone Turnover Markers Over Time -- NTx(at baseline, 4, and 8 weeks)
- Change in Serum Bone Turnover Markers Over Time -- OC(at baseline, 4, and 8 weeks)
- Change in Serum Bone Turnover Markers Over Time -- OPG(at baseline, 4, and 8 weeks)
- Response Rate (Complete and Partial, Confirmed and Unconfirmed)(Up to 2 years)
- Change in Serum Bone Turnover Markers Over Time -- BAP(at baseline, 4, and 8 weeks)
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug(Up to 2 years)
- Mean Patient-reported Pain(Baseline, 8, 16, and 24 weeks)
- MUC-1 Antigen Response(at 4, 8, 16, and 24 weeks)
- Change in Serum Bone Turnover Markers Over Time(at baseline, 4, and 8 weeks)
- Change in Serum Bone Turnover Markers Over Time -- TRAP(at baseline, 4, and 8 weeks)