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    Summary
    EudraCT Number:2016-000494-20
    Sponsor's Protocol Code Number:ABC-SE
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-20
    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 number2016-000494-20
    A.3Full title of the trial
    A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Based Treatment with Focus on Mechanisms of Resistance to Endocrine Based Treatment (fulvestrant/aromatase inhibitors alone or in combination with a cdk4/6 inhibitor) in Patients With Advanced Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Based Treatment with Focus on Mechanisms of Resistance to Endocrine Based Treatment (fulvestrant/aromatase inhibitors alone or in combination with a cdk4/6 inhibitor) in Patients With Advanced Breast Cancer
    A.4.1Sponsor's protocol code numberABC-SE
    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 SponsorSkåne University Hospital, Department of Oncology
    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 supportSkåne University Hospital, Department of Oncology
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSkåne University Hospital, Department of Oncology
    B.5.2Functional name of contact pointAna Bosch Campos
    B.5.3 Address:
    B.5.3.1Street AddressGetingevägen 4
    B.5.3.2Town/ cityLund
    B.5.3.3Post code221 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+4646 17 75 20
    B.5.5Fax number+4646 17 60 23
    B.5.6E-mailana.bosch_campos@med.lu.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 Atorvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA Sverige 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.3.1Product nameAtorvastatin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATORVASTATIN
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Estrogen receptor positive metastatic or locally advanced inoperable breast cancer.
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer that is sensitive to endocrine treatment.
    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 study superiority of the combination of endocrine based treatment and atorvastatin when compared to endocrine based treatment
    alone, in terms of clinical benefit rate, Progression Free Survival (PFS), Objective Response Rate (ORR; the proportion of patients with a best
    overall response- complete response or partial response), Time-To-Progression (TTP), Duration of Clinical Benefit (DCB), Overall Survival (OS).
    E.2.2Secondary objectives of the trial
    To establish safety and tolerability of the combination of endocrine based treatment with atorvastatin.
    To elucidate mechanisms of resistance to endocrine based treatment alone or in combination with statins in ER+ metastatic breast cancer.

    Translational:
    1. To study treatment effects in terms of tumor marker expression in primary tumor, the untreated metastatic tumor, and upon progression
    2. To analyse circulating markers measured at inclusion, every third month, and upon progression (e.g. biomarkers of
    immunology, lipid-metabolism, and endocrine response as well as circulating tumor DNA)
    3. To establish a comparison in the genomic profile of the circulating tumor DNA (ctDNA) and the biopsies of the metastatic lesions. Evaluate
    the findings of the genomic changes in ctDNA before treatment and upon progression to endocrine based treatment
    with those in the FFPE biopsies obtained at the same time points.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients diagnosed with ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic
    endocrine based treatment. If IHC analysis is not available from the metastatic tissue, the ER and HER2 status is determined from archived
    primary tumor.
    2. Age > 18 years.
    3. Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
    4. Metastatic disease must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination,
    computerized tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). Bone
    metastases alone are allowed.
    5. Pre-menopausal patients must consent to undergo either surgical or chemical castration during the duration of the treatment and utilize an
    effective contraception barrier method.
    6. Patient not willing to undergo study specific biopsy from the metastatic site should preferably have enough metastatic tumor sample
    material archived to perform DNA extraction from formalin fixed paraffin embedded (FFPE) material.
    7. Patient must be capable and willing to grant signed informed consent prior to any procedure related with this study as well as to allow
    access to FFPE biopsies for DNA extraction and for serial CTCs ctDNA analysis. Biopsy of the metastatic site upon progression is not
    mandatory but desirable.
    8. Signed informed consent according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    1. Previous treatment for metastatic breast cancer (previous systemic treatment for early breast cancer allowed).
    2. Brain as the only site of metastatic breast cancer.
    3. Ongoing treatment with statins (e.g. simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, or rosuvastatin), anion-exchangers (e.g.
    colestyramin or colesevelam), fibrates (e.g. gemfibrozil), nicotin-acids (or acipimox) or inhibitors of intestinal cholesterol uptake (e.g.
    ezitimibe) for the first part of the trial.
    4. Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal
    dysfunction (creatine kinase level) more than three times the upper limit of the normal range.
    5. The patient is unable to pause treatment with anticoagulants/antiagregants prior to biopsy during the recommended times.
    6. History of haemorrhagic stroke.
    7. Pregnancy or breast-feeding.
    8. Untreated psychiatric disorders that will impair the patient’s ability to comply with study treatment or protocol.
    9. History of allergic reactions attributed to compounds of similar chemical or biological composition to either of the study drugs.

    E.5 End points
    E.5.1Primary end point(s)
    Clinical benefit rate, defined as the proportion of all randomly assigned patients who have the best overall response rate at cut-off time for data analysis following first-line endocrine based therapy alone contrasted to endocrine based therapy plus atorvastatin. Data cut-off time has been pre-specified as 9 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical benefit rate, which is defined as the proportion of all randomly assigned patients who have a best overall response of a complete response (CR), a partial response (PR), or stable disease (SD) for at least 24 weeks following first-line letrozole treatment vs. letrozole and atorvastatin.
    E.5.2Secondary end point(s)
    1) Progression free survival comparing endocrine based treatment alone or endocrine based treatment in combination with atorvastatin in
    patients with metastatic breast cancer.
    2) Objective Response Rate (ORR; the proportion of patients with a best overall response- complete response or partial response).
    3) Time-To-Progression (TTP).
    4) Duration of Clinical Benefit (DCB).
    5) Overall survival.
    6) Safety and tolerability


    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Progression free survival (PFS) is defined as the time elapsing between the time of random assignment to treatment and the date of the earliest evidence of objective disease progression or death of any cause before documented disease-progression.
    2. Time-To-Progression (TTP) defined as time elapsed between date of diagnosis of metastatic disease and date of confirmation of disease progression in the first part of the protocol.
    3. Duration of Clinical Benefit (DCB) includes complete response, partial response and disease stabilization.
    4. Overall survival defined as the time elapsed from the date of first confirmation of metastatic disease and the date of death from any cause.
    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 Yes
    E.6.5Efficacy Yes
    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
    Translational:
    To study treatment effects in terms of molecular profile (genomic and transcriptomic) in primary tumor, the untreated metastatic tumor,
    and upon progression.

    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 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 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
    The trial will end once the last recruited patient has been in treatment for 9 months. This is so because of the primary end-point of clinical benefit rate. 9 months is the pre-specified time to be able to evaluate either stable disease, partial or complete response.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state126
    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)
    Upon study exit patients will receive standard of care for metastatic breast cancer according to the guidelines in the South Sweden Breast Cancer Group.
    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 Decision2016-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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