Clinical trial
T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
Name
202100318
Description
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.
Trial arms
Trial start
2022-11-10
Estimated PCD
2024-10-03
Trial end
2024-10-03
Status
Active (not recruiting)
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.
Arms:
treatment
Size
5
Primary endpoint
Safety profile
At 8 weeks and follow-up through study completion, an average of 1 year
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Male patients with metastatic BC (n=6)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2024-05-03
1 organization
1 product
1 indication
Organization
University Medical Center GroningenProduct
AndroGelIndication
Male Breast Cancer