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    Summary
    EudraCT Number:2017-005124-24
    Sponsor's Protocol Code Number:6378707817
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-16
    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 number2017-005124-24
    A.3Full title of the trial
    Therapeutic Drug Monitoring guided tamoxifen dosing: a feasibility study in patients with hormone positive breast cancer
    Therapeutic Drug Monitoring gestuurde tamoxifen dosering: een haalbaarheidsstudie in patiënten met hormoon gevoelige borstkanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapeutic Drug Monitoring guided tamoxifen dosing: a feasibility study in patients with hormone positive breast cancer
    Therapeutic Drug Monitoring gestuurde tamoxifen dosering: een haalbaarheidsstudie in patiënten met hormoon gevoelige borstkanker
    A.4.1Sponsor's protocol code number6378707817
    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 SponsorErasmus MC Cancer Institute
    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 supportErasmus MC Cancer Institute
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointS.L.W. Koolen
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.6E-mails.koolen@erasmusmc.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 Yes
    D.2.1.1.1Trade name tamoxifen
    D.2.1.1.2Name of the Marketing Authorisation holderMylan B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Hormone positive breast cancer
    hormoongevoelige borstkanker
    E.1.1.1Medical condition in easily understood language
    Hormone positive breast cancer
    hormoongevoelige borstkanker
    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 prove that TDM of tamoxifen is feasible in clinical practice.
    Onderzoeken of TDM van tamoxifen haalbaar is in de klinische praktijk.
    E.2.2Secondary objectives of the trial
    1. To determine the relation between the pharmacokinetics (PK) of tamoxifen and its metabolites and relevant adverse effects.
    2. To investigate the effects of TDM on patient compliance, based on validated questionnaires.
    3. To prove that TDM of tamoxifen is cost effective in clinical practice.
    4. To investigate the incidence of non-alcoholic fatty liver disease after 2 years of tamoxifen therapy.
    5. To investigate the effects of food on the pharmacokinetics (PK) of tamoxifen and its metabolites.
    6. To investigate the effects of lowering the tamoxifen dose in patients with severe side effects and an endoxifen concentration of >32 nmol/L on the level of adverse effects.
    7. To evaluate the effect of two year tamoxifen treatment on objective and subjective cognitive functioning, measured by validated online cognitive tests and questionnaires and to investigate the association between tamoxifen dose, tamoxifen plasma concentrations and cognitive functioning.
    1. De relatie tussen de farmacokinetiek (PK) van tamoxifen en de metabolieten en relevante bijwerkingen in kaart brengen.
    2. Onderzoeken of er een effect is van de interventie TDM op de mate van therapietrouw.
    3. Onderzoeken of TDM van tamoxifen kosten-effectief is in de klinische praktijk.
    4. Onderzoeken wat de incidentie is van niet-alcoholische leververvetting 2 jaar na behandeling met tamoxifen.
    5. Onderzoeken wat het effect van voedsel is op de farmacokinetiek (PK) van tamoxifen en de bijbehorende actieve metabolieten.
    6. Onderzoeken wat het effect van een lagere tamoxifen dosering in patiënten met bijwerkingen en een endoxifen concentratie >32 nmol/L op de mate van bijwerkingen.
    7. Onderzoeken wat het effect is van 2 jaar tamoxifen gebruik op het cognitief functioneren en onderzoeken of er een associatie is tussen de tamoxifen dosering, tamoxifen en endoxifen plasma concentraties en het cognitief functioneren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult women (≥ 18 years of age) who are planned to start adjuvant tamoxifen therapy.
    2. WHO Performance Status ≤ 1
    3. Able and willing to sign the Informed Consent Form prior to screening evaluations
    4. Able and willing to undergo blood sampling for PK analysis.
    1. Volwassen vrouwen (≥ 18 jaar) waarbij het voornemen is om te starten met adjuvante tamoxifen therapie.
    2. WHO Performance Status ≤ 1 .
    3. In staat om het Informed Consent formulier te tekenen vooraf aan de screening evaluatie.
    4. In staat en bereid om bloed te laten prikken voor de PK analyse.
    E.4Principal exclusion criteria
    1. Woman who are pregnant or breast feeding;
    2. Endometrial cancer (diagnosis < 3 years ago)
    3. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
    4. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair treatment compliance.
    5. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of tamoxifen or puts the patient at high risk for treatment related complications.
    6. ≥3 months tamoxifen treatment without TDM or start dose >20 mg OD.
    1. Vrouwen die zwanger zijn of borstvoeding geven.
    2. Patiënten die <3 jaar geleden zijn gediagnosticeerd met endometrium kanker.
    3. Symptomatische CZS metastasen of een historie met een psychiatrische aandoening, waardoor men niet in staat is om de informatie te begrijpen en Informed Consent te geven.
    4. Patiënten met een bekend alcoholisme probleem, drugsverslaafden and/of psychiatrische of fysiologische conditie waarmee de patiënt naar het inzicht van de onderzoeker niet in staat is om de aanwijzingen van de behandelingen nauwlettend op te volgen.
    5. Aanwijzingen voor enige andere ziekte, neurologische of metabole disfunctie, vastgesteld bij lichamelijk onderzoek of bij laboratoriumonderzoek, hetgeen leidt tot een contra-indicatie voor het gebruik van tamoxifen of een hogere risico op complicaties bij het gebruik van tamoxifen.
    6. ≥3 maanden behandeling met tamoxifen zonder TDM of een startdosering >20 mg eenmaal daags.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients with an adequate TDM target level (endoxifen blood level ≥16 nmol/L) at month 6 after start of tamoxifen treatment in comparison with the percentage patients with an adequate TDM target level (endoxifen blood level ≥16 nmol/L) at month 1 after start of tamoxifen treatment.
    Na 6 maanden wordt het percentage patiënten met een adequate endoxifenspiegel (≥16 nmol/L) geëvalueerd in vergelijking met het percentage maand na start.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months .
    Na 6 maanden.
    E.5.2Secondary end point(s)
    1. To determine the safety (Adverse Events) in relation with pharmacokinetic parameters, such as endoxifen steady state concentrations) of TDM guided dosing.
    2. To determine the patient compliance and quality of life after 1, 6 and 24 months after start tamoxifen treatment in comparison with the baseline. We will evaluate compliance with the MORISKY 8 scale scores during this intervention study.
    3. To evaluate the direct medical costs needed to monitor all patients to adequately adjust subtherapeutic patients. To determine the Quality of Life after 1, 6 and 24 months after start tamoxifen treatment in comparison with the baseline, we will evaluate Quality of Life with the EORTC QLQ BR23 questionnaire
    4. To evaluate the incidence of non-alcoholic fatty liver disease 24 months after start of tamoxifen treatment in comparison with the baseline (0-3 months after start of tamoxifen treatment)
    5. To evaluate the effects of food on the pharmacokinetics (PK) of tamoxifen and its metabolites.

    4. To evaluate the incidence of non-alcoholic fatty liver disease 24 months after start tamoxifen treatment in comparison with the baseline (0-3 months after start tamoxifen treatment.
    5. To evaluate the effects of food on the pharmacokinetics (PK) of tamoxifen and its metabolites.
    6. To investigate the effects of lowering the tamoxifen dose in patients with severe side effects and an endoxifen concentration of >32 nmol/L on the level of adverse effects.
    7. The difference in the age-corrected scores on each cognitive subtest and the score of self-reported cognition between patients on two-year tamoxifen treatment and healthy controls.
    8. The association between tamoxifen dose, plasma concentrations of tamoxifen and endoxifen and score on each cognitive subtest and the score of self-reported cognition.
    1. Inzichtelijk maken van de veiligheid (bijwerkingen) van TDM-gestuurde tamoxifen dosering in relatie met farmacokinetische parameters, zoals de endoxifen steady state concentraties.
    2. Inzichtelijk maken van de therapietrouw na 1, 6 en 24 maanden na start met de tamoxifen behandeling in vergelijking met de baseline. De therapietrouw wordt geëvalueerd aan de hand van de MORISKY 8 scale scores gedurende deze interventie studie.
    3. Evaluatie van de directe medische kosten die gemaakt worden om patiënten een adequate spiegel te laten bereiken.
    4. Evaluatie van de incidentie niet-alcoholische leververvetting 24 maanden na start in vergelijking met de baseline (0-3 maanden na start met tamoxifen).
    5. Evaluatie van de invloed van voedings op de farmacokinetiek (PK) van tamoxifen en de bijbehorende actieve metabolieten.
    6. Onderzoeken wat het effect van een lagere tamoxifen dosering in patiënten met bijwerkingen en een endoxifen concentratie >32 nmol/L op de mate van bijwerkingen.
    7. Het verschil in scores op de cognitie test tussen patiënten die twee jaar tamoxifen gebruikt hebben en gezonde controles.
    8. De associatie tussen tamoxifen dosering, plasma concentraties van tamoxifen en endoxifen en de scores op de cognitie test.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study
    Einde van de studie
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    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
    LVLS
    Laatste visite van de laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    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: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 229
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state457
    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)
    Patients may continue the use of tamoxifen post trial according to regular treatment
    Patiënten kunnen het gebruik van tamoxifen continueren na de studie volgens het reguliere behandelprotocol
    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 Decision2018-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-07
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