NCT01194427终止2 期
A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Changes in Markers of Proliferation Prior to and After Study Drug Administration
研究概览
简要总结
This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.
详细描述
Key eligibility criteria include:
- Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
- No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
- No prior or current use of any therapy to treat the current breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Stage I-III invasive breast cancer
- •Awaiting surgery or neoadjuvant treatment
- •ECOG performance status 0, 1 or 2
- •Adequate organ function
- •Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)
排除标准
- •Prior or current treatment of any kind for the current breast cancer
- •Current use of any other investigational drugs
- •Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness
研究组 & 干预措施
Vorinostat and Tamoxifen
Experimental
Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
干预措施: Vorinostat and Tamoxifen (Drug)
结局指标
主要结局
Changes in Markers of Proliferation Prior to and After Study Drug Administration
时间窗: Baseline and 14 days
To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.
次要结局
未报告次要终点
研究者
研究点 (1)
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