NCT05156606

Testosterone & Tamoxifen Trial

T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Male Breast Cancer

Interventions

Type	Name	Description
DRUG	AndroGel	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.

Timeline

• Start date: 2022-11-10
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2021-12-14
• Last updated: 2024-08-09

Locations

1 site across 1 country: Netherlands