NCT00084396已完成2 期
A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Predictive model for response as assessed by gene expression profiling
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.
详细描述
OBJECTIVES:
Primary
- Develop a predictive model of response (based on gene expression profiling) in postmenopausal women with estrogen- and/or progesterone-receptor positive stage II, IIIA, or IIIB breast cancer treated with neoadjuvant letrozole.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine changes in Ki67 proliferation rates in patients treated with this drug.
- Determine the rate of improvement in surgical outcomes in patients treated with this drug.
- Determine the long-term outcomes in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine mechanisms of resistance to this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Letrozole/Surgery
Experimental
干预措施: letrozole (Drug)
Letrozole/Surgery
Experimental
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Predictive model for response as assessed by gene expression profiling
次要结局
- Rate of improvement in surgical outcomes
- Response rate
- Changes in Ki67 proliferation rates
- Long-term outcomes
- Safety
- Mechanisms of resistance
研究者
研究点 (1)
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