Testosterone & Tamoxifen Trial

• Status: Not yet recruiting
• Trial end date: 2024-01-03
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Testosterone

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 <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.