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    Summary
    EudraCT Number:2021-002170-72
    Sponsor's Protocol Code Number:202100318
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002170-72
    A.3Full title of the trial
    T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients
    A.4.1Sponsor's protocol code number202100318
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointResearch Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310503611847
    B.5.5Fax number+310503614862
    B.5.6E-mailresearchcoordinator@onco.umcg.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAndrogel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.3Other descriptive nameTestosteron/androgel
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    male breast cancer patients
    E.1.1.1Medical condition in easily understood language
    male breast cancer patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety profile (AEs, SAEs) on combined treatment with tamoxifen and testosterone.
    E.2.2Secondary objectives of the trial
    • 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 on 8 weeks FDG-PET/CT.
    • Relation between baseline imaging and tumor characteristics to treatment response.
    • Difference in adverse events between the two testosterone dosages.
    • Increase in free testosterone levels, related to treatment response and toxicity.
    • Monitoring of blood hematocrite, related to testosterone treatment.
    • CtDNA for ER mutation analysis and CTCs (for ER and AR expression) at baseline, prior to cycle 2 and 3, related to response and FES- and FDHT PET imaging.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Safety profile, defined as the number of AEs and SAEs that occur while on tamoxifen and testosterone treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluation will take place at least after 2 weeks, 4 weeks and 8 weeks. After this safety evaluations will take place at least every 4 to 12 weeks depending on the outcome of the prior evaluations.
    E.5.2Secondary end point(s)
    • 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 on 8 weeks FDG-PET/CT (assessed per lesion and per patient by quantitative analysis using standardized uptake values (SUV).
    • Relation between baseline imaging and tumor characteristics to treatment response.
    • Difference in adverse events between the two testosterone dosages.

    E.5.2.1Timepoint(s) of evaluation of this end point
    FES- and FHDT-PET will take place at baseline before the start of treatment.
    For treatment response the first evaluation with FDG-PET/CT takes place after 2 cycli (8 weeks), after this response evaluation with CT (with or without FDG-PET) will take place at least every 12 weeks.
    Adverse events will be evaluated at every visit, which is in week 2, 4 and 8 and every 4 to 12 weeks thereafter.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the last patient’s last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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