Clinical trial NCT05156606: Testosterone & Tamoxifen Trial
Official title: T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Male Breast Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Male patients with metastatic BC (n=6)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety profile
timeFrame: At 8 weeks and follow-up through study completion, an average of 1 year
Secondary outcomes:
measure: AR to ER ratio
timeFrame: At baseline
measure: Treatment response
timeFrame: 8 weeks
measure: Imaging and response
timeFrame: At 8 weeks and follow-up through study completion, an average of 1 year
measure: Adverse events based on dosages
timeFrame: At 8 weeks and follow-up through study completion, an average of 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: UMCG
name: Geke A.P. Hospers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: