A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Tumor Proliferation (Percentage of Ki-67 Positive Cells)
研究概览
简要总结
RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an effective treatment for women with breast cancer.
PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- To identify the effect of the adrenal steroid, dehydroepiandrosterone (DHEA), on tumor proliferation in women with estrogen receptor-negative, progesterone receptor-negative, HER2/neu-negative, and androgen receptor (AR)-positive stage I-III adenocarcinoma of the breast.
Secondary
- To study the effect of DHEA on expression of AR in these patients.
- To assess the effect of DHEA on changes in serum estrogen and androgen hormone levels (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) in these patients.
- To assess the toxicity of DHEA in these patients.
- To follow the clinical course of these patients.
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
- 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
DHEA, surgical resection
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
干预措施: DHEA (Drug)
DHEA, surgical resection
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
干预措施: Surgical resection (Procedure)
结局指标
主要结局
Tumor Proliferation (Percentage of Ki-67 Positive Cells)
时间窗: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
次要结局
- Toxicity(Within 48 hours prior to surgery and after 14 days of DHEA treatment.)
- Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression(Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.)
- Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)(Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.)