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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
UMCG
Groningen, Netherlands
Safety profile
Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.
Time frame: At 8 weeks and follow-up through study completion, an average of 1 year
AR to ER ratio
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).
Time frame: At baseline
Treatment response
Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).
Time frame: 8 weeks
Imaging and response
Relation between baseline imaging and tumor characteristics to treatment response.
Time frame: At 8 weeks and follow-up through study completion, an average of 1 year
Adverse events based on dosages
Difference in adverse events between the two testosterone dosages.
Time frame: At 8 weeks and follow-up through study completion, an average of 1 year
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