18FDHT-PET to visualize the effect on the androgen receptor level by bicalutamide

niversity Medical Center Groningen0 个研究点目标入组 20 人开始时间: 2015年9月22日最近更新: 2020年11月3日

试验速览

暂无简介。

•1. A history of histological proven AR-positive (i.e. >10% staining), HER2-negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy)
•2. Tumor progression after at least one line of systemic treatment
•3. Measurable disease according to RECIST 1.1; or evaluable disease
•4. Age = 18 years
•5. Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Unable to comply with the protocol.
•2. Evidence of central nervous metastases
•3. Presence of life-threatening visceral metastases
•4. Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
•5. Clinical significant cardiovascular disease (no NYHA class >2, myocardial infarction within 6 months, uncontrolled angina within 3 months, history of clinical significant ventricular arrhythmias, history of Mobitz II second or third degree heart block, uncontrolled hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 105 mmHg)
•6. Previous anti-androgen treatment
•7. Concurrent use of ER-directed anti hormonal therapies
•8. Toxicity of radiotherapy or major surgery before baseline PET scanning

发起方