Testosterone & Tamoxifen Trial

NCT05156606 | Terminated DMC

• 1 other identifier: 202100318
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• AR to ER ratio

  At baseline

• Treatment response

  8 weeks

• Imaging and response

  At 8 weeks and follow-up through study completion, an average of 1 year

• Adverse events based on dosages

  At 8 weeks and follow-up through study completion, an average of 1 year

Study Arms (1)

treatment

EXPERIMENTAL

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.

Drug: AndroGel

Interventions

AndroGel DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• A history of proven ER+ (\>10% of cells), AR+ (\>10% of cells), and HER2- metastatic BC
• Tumor progression after at least one line of conventional endocrine therapy (tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).
• Age ≥ 18 years
• 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
• Written informed consent

You may not qualify if:

• History of prostate, testicular or liver cancer
• Patients already using testosterone supplements
• Patients using medication with anti-androgenic effects (e.g. spironolactone)
• 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.
• Hematocrit \>50%
• Patients with uncontrolled hypertension, diabetes mellitus or other significant cardiovascular morbidity.
• Patients with recent history of coronary artery disease or trombo-embolic events within 6 months prior to screening
• Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
• Visceral crisis and/or rapid progression necessitating chemotherapy
• Previous allergic reaction to androgen agonists
• Contra-indication for PET imaging
• Tamoxifen or fulvestrant treatment \<5 weeks prior to FES-PET.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms, Male

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Geke A.P. Hospers, MD,PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Male patients with metastatic BC (n=6)

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 14, 2021
• Study Start: November 10, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

NL (1)