Male Breast CancerT&TNCT05156606
Testosterone & Tamoxifen Trial
A study testing AndroGel in people with Male Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Breast Cancer
- What is being tested?
- AndroGel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Nov 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
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
- Being tested
- AndroGel
- Medical subject headings
- Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroGelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AndroGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile
Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.
Measured: At 8 weeks and follow-up through study completion, an average of 1 year
Secondary outcomes (4)
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).
Measured: At baseline
Treatment response
Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).
Measured: 8 weeks
Imaging and response
Relation between baseline imaging and tumor characteristics to treatment response.
Measured: At 8 weeks and follow-up through study completion, an average of 1 year
Adverse events based on dosages
Difference in adverse events between the two testosterone dosages.
Measured: At 8 weeks and follow-up through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start10 Nov 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Five patients were included; it did not succeed in recruiting the target number of 6 patients. This is as a result of the rarity of this disease in men.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Male patients with metastatic BC (n=6)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geke A.P. Hospers, MD,PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156606
- Sponsor's protocol ID
- 202100318
- Acronym
- T&T
- Status last verified
- Aug 2024
- First submitted
- 16 Nov 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05156606
- Acronym / sponsor ID
- T&T / 202100318
- Conditions
- Male Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Five patients were included; it did not succeed in recruiting the target number of 6 patients. This is as a result of the rarity of this disease in men.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Male patients with metastatic BC (n=6)
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: AndroGelAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndroGelAfter 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 | treatment |
Primary outcome
Safety profile
Time frame: At 8 weeks and follow-up through study completion, an average of 1 year
Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.
4 secondary outcomes
AR to ER ratio
Time frame: At baseline
Treatment response
Time frame: 8 weeks
Imaging and response
Time frame: At 8 weeks and follow-up through study completion, an average of 1 year
Adverse events based on dosages
Time frame: At 8 weeks and follow-up through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Five patients were included; it did not succeed in recruiting the target number of 6 patients. This is as a result of the rarity of this disease in men.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geke A.P. Hospers, MD,PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AndroGel in people with Male Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Five patients were included; it did not succeed in recruiting the target number of 6 patients. This is as a result of the rarity of this disease in men.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile (time frame: At 8 weeks and follow-up through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.