Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers: The EMPOwER Study
试验速览
- 阶段
- 2 期
- 入组人数
- 82
- 主要终点
- Endocrine Therapy response
研究概览
简要总结
Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers
详细描述
The clinical trial will be a prospective, two strata, non-blinded, single institution, Health Canada approved, Window of Opportunity trial with 2 weeks of pre-surgical endocrine therapy using either anastrozole or tamoxifen. Tissue from the initial biopsy and from surgery will be sent for Ki67 analysis using the NanoString® Assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Any patient with histologically confirmed newly diagnosed operable ER+, Her2 negative invasive carcinoma on diagnostic core biopsy that has a radiographic size ≥ 1.5 cm
- •Histology has to be ductal, lobular or mixed
- •Surgery date planned in the next 2-6 weeks
- •Negative pregnancy test if of child baring potential
- •Post-menopausal status verified by FSH and Estradiol (with 6 months of amenorrhea)
排除标准
- •Previous treatment with endocrine therapy, chemotherapy or chest wall radiation within last 6 months
- •Known metastatic or recurrent breast cancer.
研究组 & 干预措施
Endocrine Therapy
Anastrozole 1 mg (postmenopausal) or tamoxifen 20mg (premenopausal) are to be taken orally each evening and would be started exactly 2 weeks prior to their surgery.
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Endocrine Therapy response
时间窗: at one year
Introduction and validation of the use of NanoString® technology and a development of a custom gene codeset predictive of endocrine therapy response into the window setting as a more robust and reliable method of biomarker assessment as compared to Ki67.
次要结局
- Biomarker Predictive value(at one year)