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Testosterone & Tamoxifen Trial (T&T)

U

University Medical Center Groningen (UMCG)

Status

Terminated

Conditions

Male Breast Cancer

Treatments

Drug: AndroGel

Study type

Interventional

Funder types

Other

Identifiers

NCT05156606
202100318

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

treatment
Experimental group
Description:
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.
Treatment:
Drug: AndroGel

Trial contacts and locations

1

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Central trial contact

Geke A.P Hospers, MD,PhD; Jasper J.L. van Geel, MD

Data sourced from clinicaltrials.gov

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