Testosterone & Tamoxifen Trial

Not Applicable

Terminated

• Conditions: Male Breast Cancer
• Interventions: Drug: AndroGel

• Registration Number: NCT05156606
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Study Start: 2022-11-10
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands