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    Summary
    EudraCT Number:2017-000317-22
    Sponsor's Protocol Code Number:BRE-ASA01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-17
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-000317-22
    A.3Full title of the trial
    A pilot study of low dose acetylsalicylic acid (ASA) for reduction of breast density and inflammation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin for reduction of breast density and inflammation
    A.3.2Name or abbreviated title of the trial where available
    BRE-ASA
    A.4.1Sponsor's protocol code numberBRE-ASA01
    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 SponsorLinköping University
    B.1.3.4CountrySweden
    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 supportSwedish Research Council
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish Cancer Society
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLinköping University
    B.5.2Functional name of contact pointCharlotta Dabrosin
    B.5.3 Address:
    B.5.3.1Street AddressDept. of Clinical and Experimental Medicine, Faculty of Medicine
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58183
    B.5.3.4CountrySweden
    B.5.6E-mailcharlotta.dabrosin@liu.se
    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 Trombyl
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    Healthy volunteers
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 investigate whether the in vivo extracellular levels of IL-6, IL-8, or CCL5 decrease in dense breast tissue in women treated with ASA compared to untreated controls.
    E.2.2Secondary objectives of the trial
    • To investigate whether LTF measured by MRI decrease in dense breast tissue in women treated with ASA compared to untreated controls.
    • To investigate whether the amount and type of inflammatory cells are affected in dense breast tissue in women treated with ASA compared to untreated controls.
    • To investigate whether other biological markers associated with breast carcinogenesis or inflammation such as the extracellular in vivo expression of panels of proteins, microRNAs and amino acids are affected in dense breast tissue in women treated with ASA compared to untreated controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Postmenopausal women defined as > 12 months since last menstruation
    •55-74 years of age
    •A baseline left breast density score of > 75% as measured by standard digital
    mammography (BIRADs score D)
    •A willingness to follow the study protocol, as indicated by provision of informed consent to participate
    •A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
    •Healthy without serious co-morbidity, according to the investigators decision
    •Normal renal function as determined by a serum creatinine < upper limit of normal
    E.4Principal exclusion criteria
    •Abnormal finding on MRI at screening
    •Any sex steroid containing systemic hormonal therapy including postmenopausal replacement therapy and hormonal IUD (intrauterine device) ongoing or within the last 3 months
    •Previously affected or treated breasts including irradiation and reductive surgery. Diagnostic and investigative punctures are allowed.
    •Current or anticipated need for daily NSAID use including ASA for cardiovascular protection
    •Known intolerance to NSAIDs
    •History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
    •Known contraindication to NSAID use
    •History of breast cancer including in situ disease
    •Diabetes requiring drug therapy
    •Current smoker
    •Uncontrolled hypertension
    •History of GI ulcers, chronic GERD (reflux disease), or GI bleeding in the past 5 years
    •History of a bleeding diathesis or current anticoagulant therapy
    •History of claustrophobia
    •MR contraindications according to the radiologist’s decision
    •Allergy to gadolinium contrast
    E.5 End points
    E.5.1Primary end point(s)
    IL-6, IL-8 and CCL5 levels in breast extracellular fluids obatined by microdialysis and measured using immune based methods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six months after treatment with ASA or no treatment.
    E.5.2Secondary end point(s)
    * Breast density measured as Lean Tissue Fraction from magnetic resonance images
    * The amount and type of inflammatory cells in breast tissue biopsies.
    * Other biological markers associated with breast carcinogenesis or inflammation such as the extracellular in vivo expression of panels of proteins, microRNAs and amino acids.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Six months after treatment with ASA or no treatment.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Investigation of biological processes in dense breast tissue in post menopausal women
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment control
    E.8.2.4Number of treatment arms in the trial2
    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
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state50
    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 Decision2017-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-28
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