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    Summary
    EudraCT Number:2022-002426-28
    Sponsor's Protocol Code Number:81896-PREDICTAM
    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:2022-08-02
    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 number2022-002426-28
    A.3Full title of the trial
    Predicting an accurate tamoxifen dose: a feasibility study in patients with hormone positive breast cancer
    Het voorspellen van de juiste dosering tamoxifen: een haalbaarheid studie in patienten met hormoongevoelige borstkanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tamoxifen prediction study in patients with hormone positive breast cancer: the PREDICTAM study
    Tamoxifen predictie in patienten met hormoongevoelige borstkanker: de PREDICTAM studie
    A.3.2Name or abbreviated title of the trial where available
    PREDICTAM
    PREDICTAM
    A.4.1Sponsor's protocol code number81896-PREDICTAM
    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.M. Buijs
    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.buijs@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.3.1Product nameTamoxifen
    D.3.2Product code 30049048
    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
    The primary objective of this study is to determine the proportion of patients that reach an endoxifen level of 16 nmol/L or higher using MIPD.
    Het bepalen van de proportie patienten dat een endoxifen waarde van 16 nmol/L of hoger bereikt door middel van predictief modelleren van de tamoxifen dosering
    E.2.2Secondary objectives of the trial
    1. To determine the total success rate of the POP-PK model as well as in different groups, stratified by dosage as predicted by the POP-PK model.
    2. To establish the predictive value of the POP-PK model for patients which will not reach the 16 nmol/L endoxifen threshold with the highest prescribed tamoxifen dose of 40 mg.
    3. To test if an early blood sample (at baseline and 4-6 weeks after baseline) is indicative for the steady-state concentration;
    4. To compare the incidence of side-effects and quality of life of breast cancer patients between baseline and the final assessment after 3 months;
    5. To investigate change in cognitive functioningbbetween the start of tamoxifen treatment and two years after start of tamoxifen treatment.
    6. To investigate the association between tamoxifen dose, tamoxifen plasma concentrations and endoxifen plasma concentrations and change in objective and subjective cognitive functioning.
    1. Het bepalen van het totale success percentage van het populatie-PK model van tamoxifen en het succes percentage in verschillende groepen, gestratificeerd per dosering
    2. Het bepalen van de predictieve waarde van het populatie-PK model for patienten die een endoxifen waarde boven de 16 nmol/L niet zullen bereiken ondanks gebruik van de hoogste tamoxifen dosering van 40 mg
    3. Testen of een vroege bloedspiegel (op baseline en 4-6 weken na baseline) voorspelling is voor de steady-state concentratie
    4. Het vergelijken van bijwerkingen incidentie en kwaliteit van leven voor en 3 maanden na start van tamoxifen behandeling
    5. Het onderzoeken van het verschil in het objectief en subjectief cognitief functioneren voor start van tamoxifen en 2 jaar na start van de tamoxifen behandeling
    6. Het onderzoeken van een associatie tussen tamoxifen doseringen en tamoxifen en endoxifen plasma concentraties en de verandering in objectief en subjectief cognitief functioneren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1. Age ≥ 18 years;
    2. WHO Performance Status ≤ 1
    3. Patients with primary breast cancer, with a prescription for adjuvant tamoxifen treatment.
    4. Willing to abstain from strong and moderate CYP3A4 or CYP2D6 inhibitors or inducers, according to: CYTOCHROME P450 DRUG INTERACTION TABLE - Drug Interactions (iu.edu);
    5. Able and willing to sign the Informed Consent Form;
    6. Able and willing to undergo blood sampling for PK analysis.
    1. Leeftijd ≥ 18 jaar
    2. WHO performance status ≤ 1
    3. Patienten met primaire borst kanker en een indicatie voor adjuvante tamoxifen behandeling
    4. In staat om af te zien van sterke of matige CYP3A4 of CYP2D6 remmers of inductoren
    5. In staat zijn om het informed consent formulier te tekenen
    6. In staat en bereid zijn om bloed te laten prikken voor de PK analyse
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    1. Patients with known alcoholism, drug addiction and/or psychiatric or physiological condition which in the opinion of the investigator would impair treatment compliance;
    2. > 2 weeks of tamoxifen treatment before inclusion
    3. Patients who’s endoxifen levels have been used for therapeutic drug monitoring in the past.
    4. Evidence of a neurological disorder which might affect cognitive functioning (only for cognition scan part)
    1. Patiënten met een bekend alcoholisme probleem, drugsverslaafden and/of psychiatrische of fysiologische conditie waarmee de patient naar het inzicht van de onderzoeker niet in staat is om de aanwijzingen van de behandelingen nauwlettend op te volgen
    2. Behandeling van tamoxifen langer dan 2 weken
    3. Patienten waarbij eerder endoxifen concentraties zijn gemeten
    4. Bewijs van een neurologische ziekte die invoed kan hebben op het cognitief functioneren (alleen voor het cognitie onderdeel
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients that reach an endoxifen level of 16 nmol/L or higher after three months of tamoxifen treatment. The main study parameter is the endoxifen level at 3 months after baseline.
    de proportie patienten dat een endoxifen waarde van 16 nmol/L of hoger bereikt na 3 maanden tamoxifen therapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after inclusion
    3 maanden na inclusie
    E.5.2Secondary end point(s)
    1. The total success rate of the POP-PK model as well as in different groups, stratified by dosage as predicted by the POP-PK model.
    2. The predictive value of the POP-PK model for patients who do not reach the 16 nmol/L endoxifen threshold with the highest prescribed tamoxifen dose of 40 mg;
    3. The correlation between the endoxifen values from an early blood sample (at baseline and 4-6 weeks after baseline) and the steady-state concentration of endoxifen;
    4. The difference in incidence of side-effects and quality of life between baseline and 3 months after tamoxifen treatment as determined by FACT-ES questionnaires.
    5. The intra-patient difference in cognitive test performance and self-reported cognition between baseline and after two years of tamoxifen treatment.
    6. The association between tamoxifen, dose, plasma concentrations of tamoxifen and endoxifen and intra-patient differences in cognitive test performance and self-reported cognition.
    1. Het totale succes percentage van het POP-PK model en het succes percentage in verschillende groepen, gestratificeerd per dosering.
    2. de predictieve waarde van het populatie-PK model voor patienten die een endoxifen waarde boven de 16 nmol/L niet zullen bereiken ondanks gebruik van de hoogste tamoxifen dosering van 40 mg
    3. Testen of een vroege bloedspiegel (op baseline en 4-6 weken na baseline) voorspellend is voor de steady-state concentratie
    4. Het verschil in bijwerkingen incidentie en kwaliteit van leven voor en 3 maanden na start van tamoxifen behandeling
    5. Het intra-patient verschil in cognitief functioneren voor start van en 2 jaar na tamoxifen behandeling
    6. De associatie tussen tamoxifen dosering en tamoxifen en endoxifen plasma concentraties en intra-patient verschillen in cognitief functioneren
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months after inclusion
    3 maanden na inclusie
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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
    Last visit of last subject
    Laatste visite van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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)
    Patient may continue the use of tamoxifen post trial according to regular treatment
    Patienten 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 Decision2022-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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