NCT02650817已完成1 期
A Phase IB Study to Evaluate the Effect of RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer Lesions Using 16α-18F-Fluoro-17β-Estradiol Positron Emission Tomography Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Effect of ER Binding after RAD1901 treatment
研究概览
简要总结
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)
详细描述
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) using 16α-18F-Fluoro-17β-estradiol (FES) positron emission tomography (PET) imaging
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
- •Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC
- •Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting
- •Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease
- •Greater than or equal to 18 years of age
- •Patients must be post-menopausal
- •Life expectancy >3 months
排除标准
- •Greater than 3 lines of endocrine therapy for metastatic disease.
- •Prior anti-cancer treatment or investigational drug therapy within the following windows:
- •Tamoxifen or fulvestrant therapy < 42 days before 1st 18FES-PET scan
- •Any other anti-cancer endocrine therapy < 14 days before 1st dose of study drug
- •Any chemotherapy < 28 days before 1st dose of study drug
- •Any investigational drug therapy < 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug
- •Patients with untreated or symptomatic central nervous system (brain) metastases
- •Patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts
研究组 & 干预措施
Elacestrant (formerly RAD1901)
Experimental
To receive daily oral elacestrant
干预措施: RAD1901 (Drug)
结局指标
主要结局
Effect of ER Binding after RAD1901 treatment
时间窗: 14 Days after the first dose
To determine the effect of RAD1901 treatment on the estrogen receptor (ER) expression and estradiol binding to the ER in lesions from patients with metastatic breast cancer (mBC)
次要结局
- Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines(Every 8 weeks for to up 12 months of treatment)
- Correlation of FES uptake after RAD1901 treatment to clinical response(Every 8 weeks for to up 12 months of treatment)
- Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values(Up to 30 days after the end of treatment)
- Plasma concentrations of RAD1901 will be assessed at predefined intervals(Every 28 days for up to 3 cycles)
研究者
研究点 (5)
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