T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients

niversity Medical Center Groningen0 个研究点目标入组 6 人开始时间: 2022年4月4日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•2.A history of proven ER+ (>10% of cells), AR+ (>10% of cells), and HER2- metastatic BC
•3.Tumor progression after at least one line of conventional endocrine therapy
•(tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).
•4.Age = 18 years
•5.Adequate hematological, renal and liver function as follows:
•Absolute neutrophil count > 1.5 x 109/L
•Platelet count >100 x 109/L
•White blood cell count >3 x 109/L
•AST and ALT <2.5 or <5.0 in case of liver metastases x upper limit of normal (ULN)
•Creatinine clearance >50mL/min
•Prothrombin time, partial thromboplastin time and INR <1.5 x ULN
•6.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 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1.History of prostate, testicular or liver cancer
•2.Patients already using testosterone supplements
•3.Patients using medication with anti-androgenic effects (e.g. spironolactone)
•4.Elevated PSA (>4µg/L) or severe urinary tract problems (as defined with a Prostate Symptom Score >19). Patients with known BRCA mutation and PSA ?3 µg/L will be referred to the urologist for prostate cancer screening, and can participate if they have no signs of prostate cancer.
•5.Hematocrit >50%
•6.Patients with uncontrolled hypertension, diabetes mellitus or other
•significant cardiovascular morbidity.
•7.Patients with recent history of coronary artery disease or trombo-embolic
•events within 6 months prior to screening
•8.Severe concurrent disease, infection, co morbid condition that, in the
•judgment of the investigator would make the patient inappropriate for
•9.Visceral crisis and/or rapid progression necessitating chemotherapy
•10.Previous allergic reaction to androgen agonists
•11.Contra-indication for PET imaging
•12.Tamoxifen or fulvestrant treatment <5 weeks prior to FES-PET.

发起方