Fluorine-18 Fluoroestradiol Positron Emission Tomography-computed Tomography: an in Vivo Biomarker Predicting Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To evaluate the accuracy of the change of FES uptake in predicting progression-free survival(PFS) in patients treated with fulvestrant 500 mg
研究概览
简要总结
Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this study we will determine the utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen positive metastatic breast cancer
详细描述
More than 70% of patients with metastatic breast cancer present with hormone receptor positive disease and for whom hormonal therapy is the preferred treatment approach. First-line treatment recommendations for women with hormone receptor positive locally advanced or metastatic disease includes a generation aromatase inhibitors or tamoxifen. Fulvestrant, a 17β-estradiol analog, is an antiestrogen that suppresses estrogen signaling by binding to ER and inducing oestrogen receptor degradation and has estrogen antagonistic activity but no estrogen agonistic effect. Fulvestrant has been shown to have superiority over other endocrine therapy in a series of randomized controlled trials.
The whole-body imaging of the availability of ER using FES-PET may prove valuable to evaluate the effects of fulvestrant on the ER non-invasively in individual patients. This potentially allows early prediction of therapy efficacy to fulvestrant in women with estrogen positive metastatic breast cancer.
In this pilot-study we will evaluate 35 patients who received fulvestrant as treatment for metastatic breast cancer. All patients will undergo FES-PET/CT at baseline and FES-PET after 28 days. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence.
- •No previous fulvestrant treatment
- •ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of aromatase inhibitors is allowed.
- •Life expectancy > 6 months
- •Informed consent obtained
- •Able to comply with the protocol
排除标准
- •Presence of life-threatening visceral metastases
- •Evidence of central nervous system metastases
- •> 3 lines of endocrine therapy for metastatic disease
- •Isolated liver metastasis (high FES uptake by normal liver)
研究组 & 干预措施
fulvestrant
500mg fulvestrant on days 0, 14, 28 and every 28 days thereafter Fluoroestradiol-PET is performed at baseline and after 28 days
干预措施: Fluoroestradiol (18F) (Drug)
结局指标
主要结局
To evaluate the accuracy of the change of FES uptake in predicting progression-free survival(PFS) in patients treated with fulvestrant 500 mg
时间窗: baseline; 28 days
The FES-uptake will be calculated for all tumor lesions in individual patient at baseline and 28 days. Therapy response will be monitored by regular follow-up. RECIST criteria and clinical benefit will be used as criteria. All patients will be followed up until disease progression.
次要结局
- Evaluate the heterogeneity of ER among different metastatic sites in breast cancer patients in vivo(baseline)
研究者
Zhimin Shao
professor
Fudan University