male breast cancer patients
Conditions
Interventions
Product Name: Androgel
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
Other descriptive name: Testosteron/androgel
Concentration unit: mg milligram(s)
Concentration type: up to
Concentrati
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 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 50mL/min • Prothrombin time, partial thromboplastin time and INR =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 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 enrollment 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile (AEs, SAEs) on combined treatment with tamoxifen and testosterone.;Secondary Objective: •AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV) and/or tumor tissue (assessed by percentage of ER and AR expression). •Treatment response on 8 weeks FDG-PET/CT. •Relation between baseline imaging and tumor characteristics to treatment response. •Difference in adverse events between the two testosterone dosages. •Increase in free testosterone levels, related to treatment response and toxicity. •Monitoring of blood hematocrite, related to testosterone treatment. •CtDNA for ER mutation analysis and CTCs (for ER and AR expression) at baseline, prior to cycle 2 and 3, related to response and FES- and FDHT PET imaging. ;Primary end point(s): Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.;Timepoint(s) of evaluation of this end point: Safety evaluation will take place at least after 2 weeks, 4 weeks and 8 weeks. After this safety evaluations will take place at least every 4 to 12 weeks depending on the outcome of the prior evaluations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV)) and/or tumor tissue (assessed by percentage of ER and AR expression). • Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV). • Relation between baseline imaging and tumor characteristics to treatment response. • Difference in adverse events between the two testosterone dosages. ;Timepoint(s) of evaluation of this end point: FES- and FHDT-PET will take place at baseline before the start of treatment. For treatment response the first evaluation with FDG-PET/CT takes place after 2 cycli (8 weeks), after this response evaluation with CT (with or without FDG-PET) will take place at least every 12 weeks. Adverse events will be evaluated at every visit, which is in week 2, 4 and 8 and every 4 to 12 weeks thereafter. | — |
Countries
Netherlands
Contacts
Public ContactResearch Coordinator
University Medical Center Groningen
Outcome results
None listed