Testosterone & Tamoxifen Trial

NCT ID: NCT05156606

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2024-07-31

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.

Conditions

Male Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

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.

Group Type: EXPERIMENTAL

AndroGel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geke A.P. Hospers, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

UMCG

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

202100318

Identifier Type: -

Identifier Source: org_study_id