Male Breast Cancer Clinical Trial
— T&TOfficial title:
T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
Verified date | May 2024 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 5 |
Est. completion date | October 3, 2024 |
Est. primary completion date | October 3, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMCG | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety profile | Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment. | At 8 weeks and follow-up through study completion, an average of 1 year | |
Secondary | 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). | At baseline | |
Secondary | Treatment response | Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV). | 8 weeks | |
Secondary | Imaging and response | Relation between baseline imaging and tumor characteristics to treatment response. | At 8 weeks and follow-up through study completion, an average of 1 year | |
Secondary | Adverse events based on dosages | Difference in adverse events between the two testosterone dosages. | At 8 weeks and follow-up through study completion, an average of 1 year |
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