Pilot Study to Evaluate the Effect of Sunitinib on Occult Tumor Cells in the Bone Marrow of Patients With High Risk Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 主要终点
- Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with stage I, stage II, or stage III breast cancer who have tumor cells in the bone marrow.
详细描述
OBJECTIVES:
Primary
- To determine the effect of sunitinib malate on occult tumor cells (OTC) in the bone marrow of patients with high-risk stage I-III breast cancer.
Secondary
- To evaluate the number of patients who are able to tolerate this drug for 6 months and complete the study.
- To evaluate the toxicities of this drug in these patients.
- To evaluate the effects of this drug on OTC in peripheral blood.
- To evaluate correlative markers, including endothelial cells, soluble cKIT, and VEGF.
- To evaluate relapse-free and overall survival of patients treated with this drug.
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 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
sunitinib
Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer
干预措施: sunitinib malate (Drug)
sunitinib
Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer
干预措施: flow cytometry (Other)
sunitinib
Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer
干预措施: immunohistochemistry staining method (Other)
sunitinib
Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow
时间窗: Baseline, 6 months after start of treatment
DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL
次要结局
- Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study(after 6 months from start of treatment)
- Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0(up to 7 months after start of treatment)
- Relapse-free and Overall Survival(up to 3 years from beginning of treatment)
- Effect of Sunitinib Malate on OTC in Peripheral Blood(After one year of treatment)