Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT05156606
Status:
TERMINATED
Last Update Posted:
2024-08-09
First Post:
2021-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone & Tamoxifen Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Male patients with metastatic BC (n=6)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile', 'timeFrame': 'At 8 weeks and follow-up through study completion, an average of 1 year', 'description': 'Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.'}], 'secondaryOutcomes': [{'measure': 'AR to ER ratio', 'timeFrame': 'At baseline', '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).'}, {'measure': 'Treatment response', 'timeFrame': '8 weeks', 'description': 'Treatment response on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).'}, {'measure': 'Imaging and response', 'timeFrame': 'At 8 weeks and follow-up through study completion, an average of 1 year', 'description': 'Relation between baseline imaging and tumor characteristics to treatment response.'}, {'measure': 'Adverse events based on dosages', 'timeFrame': 'At 8 weeks and follow-up through study completion, an average of 1 year', 'description': 'Difference in adverse events between the two testosterone dosages.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male\n2. A history of proven ER+ (\\>10% of cells), AR+ (\\>10% of cells), and HER2- metastatic BC\n3. Tumor progression after at least one line of conventional endocrine therapy (tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).\n4. Age ≥ 18 years\n5. Adequate hematological, renal and liver function as follows:\n\n * Absolute neutrophil count \\> 1.5 x 109/L\n * Platelet count \\>100 x 109/L\n * White blood cell count \\>3 x 109/L\n * AST and ALT \\<2.5 or \\<5.0 in case of liver metastases x upper limit of normal (ULN)\n * Creatinine clearance \\>50mL/min\n * Prothrombin time, partial thromboplastin time and INR \\<1.5 x ULN\n6. Written informed consent\n\nExclusion Criteria:\n\n1. History of prostate, testicular or liver cancer\n2. Patients already using testosterone supplements\n3. Patients using medication with anti-androgenic effects (e.g. spironolactone)\n4. 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.\n5. Hematocrit \\>50%\n6. Patients with uncontrolled hypertension, diabetes mellitus or other significant cardiovascular morbidity.\n7. Patients with recent history of coronary artery disease or trombo-embolic events within 6 months prior to screening\n8. Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment\n9. Visceral crisis and/or rapid progression necessitating chemotherapy\n10. Previous allergic reaction to androgen agonists\n11. Contra-indication for PET imaging\n12. Tamoxifen or fulvestrant treatment \\<5 weeks prior to FES-PET.'}, 'identificationModule': {'nctId': 'NCT05156606', 'acronym': 'T&T', 'briefTitle': 'Testosterone & Tamoxifen Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients', 'orgStudyIdInfo': {'id': '202100318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', '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.', 'interventionNames': ['Drug: AndroGel']}], 'interventions': [{'name': 'AndroGel', 'type': 'DRUG', '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.', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Geke A.P. Hospers, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}