T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
This is a concise single arm, feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. Male patients with metastatic BC (n=6) are eligible for this study after at least 1 line of conventional endocrine therapy.
• Male
• A history of proven ER+ (\>10% of cells), AR+ (\>10% of cells), and HER2- metastatic BC
• Tumor progression after at least one line of conventional endocrine therapy (tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).
• Age ≥ 18 years
• 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
• Written informed consent