Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
研究概览
简要总结
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic 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
- 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
- •Histologically confirmed invasive breast cancer
- •Stage IIIB, IIIC with T4 lesion or Stage IV disease
- •Breast cancer must be ER-positive and/or PR-positive
- •Age ³ 18 years of age
- •ECOG performance status 0, 1 or 2
- •Able to swallow and oral medication
- •Adequate end organ function
- •Written informed consent
排除标准
- •Prior hormonal therapy for metastatic disease
- •Prior chemotherapy for metastatic disease
- •Prior treatment with sorafenib
- •Brain metastases or leptomeningeal disease
- •Evidence or history of bleeding
- •Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
研究组 & 干预措施
Sorafenib and Letrozole
干预措施: Letrozole (Drug)
Sorafenib and Letrozole
干预措施: Sorafenib (Drug)
结局指标
主要结局
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
时间窗: twenty eight days
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
次要结局
- Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib(6 months)
- Median Progressive-Free Survival (PFS)(Approximately 4.6 years)
- Overall Survival (OS) Assessed as Mean Months(Approximately 4.6 years)
研究者
Deborah Toppmeyer, MD
Professor of Medicine, Chief Medical Officer
Rutgers, The State University of New Jersey