Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Change in proliferation after statin exposure, as measured by Ki-67 level
研究概览
简要总结
RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer.
PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine differences between measures of cell proliferation (Ki-67) in women with ductal carcinoma in situ (DCIS) or stage I breast cancer receiving neoadjuvant fluvastatin sodium.
Secondary
- Determine whether statin use differentially affects specific types of DCIS/early-stage breast cancer (comedo, estrogen receptor [ER]-positive, ER-negative).
- Compare differences between tissue staining of CD68, circulating macrophages, and regulatory T cells in these patients.
- Assess the feasibility of using inherent susceptibility (mRNA polymerase chain reaction testing) to predict response to statins in these patients.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 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 fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: fluvastatin sodium (Drug)
Arm II
Patients receive oral fluvastatin sodium as in arm I at a higher dose.
干预措施: fluvastatin sodium (Drug)
Arm III
Patients do not receive fluvastatin sodium. breast Cancer surgery only
干预措施: Breast Cancer Surgery Only - Arm III (Procedure)
结局指标
主要结局
Change in proliferation after statin exposure, as measured by Ki-67 level
时间窗: up to 6 weeks
次要结局
- Blood and serum markers, including C-reactive protein, cleaved caspase 3, HER2, CD68, macrophages and immunoregulatory CD25 T cells, estrogen and progesterone receptors, mRNA, low-density lipoprotein, and cholesterol(up to 6 weeks)
- Presence of comedo necrosis(up to 6 weeks)
- Safety(up to 6 weeks)