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    Summary
    EudraCT Number:2019-002508-42
    Sponsor's Protocol Code Number:SBMASTER
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-002508-42
    A.3Full title of the trial
    A randomized, multicenter, double-blind, placebo-controlled comparison of standard (neo)adjuvant therapy plus placebo versus standard (neo)adjuvant therapy plus atorvastatin in patients with early breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MASTER: Treatment with atorvastatin versus placebo in addition to standard treatment for patients with hormone-sensitive breast cancer
    A.3.2Name or abbreviated title of the trial where available
    The MASTER study
    A.4.1Sponsor's protocol code numberSBMASTER
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportAarhus University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointSigne Borgquist
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99, Indgang C. Plan 1. Krydspunkt C108
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004522624525
    B.5.6E-mailsigne.borgquist@auh.rm.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Atorvastatin
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameAtorvastatin
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006192
    E.1.2Term Breast cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare invasive disease-free survival (IDFS) in patients randomized
    to standard (neo)adjuvant therapy plus placebo or standard
    (neo)adjuvant therapy plus atorvastatin (80 mg/day for two years).
    E.2.2Secondary objectives of the trial
    - To compare overall survival (OS), recurrence-free interval (RFI),
    distant recurrence-free interval (DRFI) including associations with first
    site of recurrence, cardiac death-free interval, and overall
    safety in the two treatment arms.
    - To investigate morbidity endpoints as specified in the morbidity subprotocol.
    - To address translational endpoints as specified in the translational subprotocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet ALL of the following criteria to be eligible for
    randomization:
    1. Women with estrogen receptor positive breast cancer who are
    candidates for (neo)adjuvant systemic therapy OR have
    received ≤3 years of adjuvant endocrine therapy.
    2. Age > 18 years.
    3. Performance status of ECOG ≤ 2.
    4. Prior to patient registration, written informed consent must be
    given according to ICH/GCP, and national/local regulations.

    E.4Principal exclusion criteria
    Patients meeting ANY one of the following criteria are not eligible:
    1. History of any prior (ipsi- and/or contralateral) invasive breast
    carcinoma.
    2. Ongoing (prevalent) cholesterol-lowering therapy (statins,
    fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be
    enrolled in the observational arm.
    3. Evidence of hepatic dysfunction (alanine aminotransferase level
    more than three times the upper limit of the normal range) or
    renal dysfunction (creatinine level more than three times the
    upper limit of the normal range).
    4. Predisposing factors for rhabdomyolysis, including
    hypothyroidism, reduced renal function, any muscle – or liver
    disease, or excessive alcohol consumption AND creatine kinase
    (CK) measured to less than five times the upper limit (CK only
    measured in case of predisposing factors).
    5. No current medication with potent CYP3A4-inhibitors (e.g.
    ketokonazole, erythromycin) or gemfibrozile, cyclosporin or
    danazol.
    6. Pregnancy or breast-feeding.
    7. Psychological, familial, sociological or geographical condition
    potentially hampering compliance with the study protocol and
    follow-up schedule; these conditions will be discussed with the
    patient before registration in the trial.
    8. History of allergic reactions attributed to compounds of similar
    chemical or biological composition to atorvastatin.

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is IDFS and is defined as the time
    between randomization and date of first occurrence of an IDFS
    event (as defined above in efficacy assessments).
    The intention-to-treat (ITT) population will be used in the primary
    analysis.
    The stratified log-rank test will be used to compare IDFS between
    the two treatment arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years
    E.5.2Secondary end point(s)
    Recurrence-Free Interval
    Distant Recurrence-Free Interval including associations with first
    site of recurrence
    Overall Survival
    Death attributable to any cause, including non-breast cancer or
    unknown cause, is considered a competing event.
    Cardiac death-free interval. Cardiac death is defined as:
    • Definitive cardiac death due to heart failure, myocardial
    infarction or documented primary arrhythmia.
    • Probable cardiac death defined as sudden, unexpected death
    within 24 hours of a definite or probable cardiac event (e.g.,
    syncope, cardiac arrest, chest pain, infarction, arrhythmia)
    without documented etiology.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    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
    The trial will end 10 years after the last patient is included.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    E.8.9.1In the Member State concerned months
    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: 3360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3360
    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 state3360
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3360
    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)
    None
    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 Decision2019-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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