Testosterone & Tamoxifen Trial

Male Breast Cancer Clinical Trial

— T&T  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05156606
• Other study ID #: 202100318
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: October 3, 2024

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

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