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Testosterone & Tamoxifen Trial (T&T)

Primary Purpose

Male Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
AndroGel
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • UMCGRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm 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.

Outcomes

Primary Outcome Measures

Safety profile
Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.

Secondary Outcome Measures

AR to ER ratio
AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV)) and/or tumor tissue (assessed by percentage of ER and AR expression).
Treatment response
Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).
Imaging and response
Relation between baseline imaging and tumor characteristics to treatment response.
Adverse events based on dosages
Difference in adverse events between the two testosterone dosages.

Full Information

First Posted
November 16, 2021
Last Updated
October 17, 2023
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT05156606
Brief Title
Testosterone & Tamoxifen Trial
Acronym
T&T
Official Title
T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Male patients with metastatic BC (n=6)
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
AndroGel
Intervention 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.
Primary Outcome Measure Information:
Title
Safety profile
Description
Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.
Time Frame
At 8 weeks and follow-up through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
AR to ER ratio
Description
AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV)) and/or tumor tissue (assessed by percentage of ER and AR expression).
Time Frame
At baseline
Title
Treatment response
Description
Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).
Time Frame
8 weeks
Title
Imaging and response
Description
Relation between baseline imaging and tumor characteristics to treatment response.
Time Frame
At 8 weeks and follow-up through study completion, an average of 1 year
Title
Adverse events based on dosages
Description
Difference in adverse events between the two testosterone dosages.
Time Frame
At 8 weeks and follow-up through study completion, an average of 1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male breast cancer patients
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geke A.P Hospers, MD,PhD
Phone
+31503612821
Email
g.a.p.hospers@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Jasper J.L. van Geel, MD
Phone
+31503616161
Email
j.j.l.van.geel@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geke A.P. Hospers, MD,PhD
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geke A.P. Hospers, MD,PhD
Phone
+31503612821
Email
g.a.p.hospers@umcg.nl
First Name & Middle Initial & Last Name & Degree
Jasper J.L. van Geel, MD
Phone
+31503616161
Email
j.j.l.van.geel@umcg.nl
First Name & Middle Initial & Last Name & Degree
Geke A.P. Hospers, MD,PhD

12. IPD Sharing Statement

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Testosterone & Tamoxifen Trial

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