FDHT-PET to visualize the effect on the androgen receptor level by bicalutamide - bicalutamide and FDHT PET in metastatic breast cancer patients

niversitair Medisch Centrum Groningen0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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. Postmenopausal status defined as one of the following:
•* Age *60 years
•* Previous bilateral oophorectomy
•* Age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists
•* Age <60 years using ER antagonists should have amenorrhea for >12 months and FSH >24U/L and LH>14U/L
•6.Adequate hematological, renal and liver function as follows:
•*Absolute neutrophil count >1.5 x 109/L
•*Platelet count >100 x 10^9/L
•* White blood cell count >3 x 10^9/L
•*AST and ALT <5.0 x upper limit of normal (ULN)
•*Creatinine clearance >50mL/min
•*Protrombin time, partial tromboplastin time and INR <1.5 x ULN
•7. Written informed consent

•1.Unable to comply with the protocol
•2.Evidence of symptomatic central nervous metastases
•3.Presence of life-threatening visceral metastases
•4.Corrected QT interval (QTc) >500millliseconds at screening
•5.Recent history of cardiac disease, including myocardial infarction, unstable angina pectoris or uncontrolled arrhythmia within 6 months prior to screening; or evidence of severe congestive heart failure with New York Heart Association severity classification > class I.
•6.Recent history of trombo-embolic events within 6 months prior to screening
•7.Hepatic impairment (Child-Pugh Class B or C)
•8.Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
•9.The concomitant use of strong CYP3A4 inhibitors (see table 1)
•10.Previous anti-androgen treatment
•11.Concurrent use of ER-directed anti hormonal therapies
•12.Toxicity of radiotherapy or major surgery not resolved before baseline PET scanning

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