Male Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGAndroGel
After the baseline imaging with FES- and FDHT-PET is completed, tamoxifen 20mg 1dd1 (standard dosage) plus testosterone (Androgel®) will be started. The first 3 patients will receive 25mg testosterone once daily (half the standard starting dosage for male hypogonadism). If this is well tolerated after 3 weeks, the dosage will be increased to 50mg once daily. Out of precaution, the safety profile of the 50mg dosage in the first 3 patients will be evaluated after all 3 patients have received 50mg testosterone for 2 cycli (8 weeks), prior to proceeding to the next 3 patients. Patients will be treated with tamoxifen and testosterone until disease progression or unacceptable toxicity.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Male patients with metastatic BC (n=6)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \<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
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 | Description |
|---|---|---|
| Safety profile | At 8 weeks and follow-up through study completion, an average of 1 year | Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AR to ER ratio | At baseline | 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 | 8 weeks | Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV). |
| Imaging and response | At 8 weeks and follow-up through study completion, an average of 1 year | Relation between baseline imaging and tumor characteristics to treatment response. |
| Adverse events based on dosages | At 8 weeks and follow-up through study completion, an average of 1 year | Difference in adverse events between the two testosterone dosages. |
Countries
Netherlands
Outcome results
None listed