T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients

Phase 1

Conditions: male breast cancer patients
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-002170-72-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 6

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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.