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    Summary
    EudraCT Number:2020-004035-24
    Sponsor's Protocol Code Number:I3Y-MC-JPCW
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-21
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-004035-24
    A.3Full title of the trial
    eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    eMonarcHER: A Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node Positive, HR+, HER2+ Breast Cancer.
    A.4.1Sponsor's protocol code numberI3Y-MC-JPCW
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    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 Verzenios
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAbemaciclib
    D.3.2Product code LY2835219
    D.3.4Pharmaceutical form Film-coated 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 INNLY2835219
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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
    High-Risk, Node-Positive, HR+, HER2+ 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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006199
    E.1.2Term Breast cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 the efficacy of abemaciclib plus physician’s choice ET versus placebo plus physician’s choice ET in the study population.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of abemaciclib plus ET versus placebo plus physician’s choice ET in the study population. (*)To assess the safety profile of abemaciclib plus physician’s choice ET versus placebo plus ET in the
    study population. (*)To evaluate participant-reported symptoms, function and global health status/QOL (EORTC QLQ-C30)
    To evaluate health status in the study population to inform decision
    modeling for health economic evaluation using the EQ-5D 5L.
    To evaluate the PK of abemaciclib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The participant has confirmed HR+, HER2-positive (HER2+) in initial diagnostic tissue, early invasive breast cancer without evidence of disease recurrence or distant metastases per STEEP criteria in Appendix 8 (Section 10.8)
    • The participant must have undergone definitive surgery of the primary breast tumor(s) AND must be randomized within 18 months of primary breast cancer surgery.
    • Have tumor tissue from breast (preferred) or lymph node
    • Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care therapy
    • Participants have completed approximately 9 months to one year of standard HER2-targeted therapy without evidence of disease recurrence (neoadjuvant/adjuvant combined duration).
    • Eligible adjuvant regimens are as follows:
    o Single agent adjuvant TDM-1 or
    o Adjuvant pertuzumab in combination with trastuzuma
    • Participant must have high risk disease is defined by 1 of the following:
    o For participants who were treated with neoadjuvant chemotherapy administered with trastuzumab-based therapy (trastuzumab
    monotherapy or in combination with other HER2-targeted therapies): The presence axillary nodal disease detected pathologically in the surgical specimen; the presence of residual disease in the breast surgical specimen may also be detected pathologically but is not required.
    o For participants who were not treated with neoadjuvant therapy: Participant’s cancer must be axillary node positive (microscopic and macroscopic tumor involvement are allowed; ipsilateral internal mammary and supraclavicular lymph nodes are allowed, but will not count toward the number of positive lymph nodes) and fulfill one of the following criteria:
     Pathological tumor involvement in ≥4 ipsilateral axillary lymph nodes
    OR
    o Pathological tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and at least 1 of the following criteria:
    o Histological Grade 2 or Grade 3 as defined by a combined score per the modified Bloom Richardson grading system (Elston and Ellis 1991), also known as the Nottingham scale, or equivalent following discussion with the Lilly CRP/CRS
    o Primary invasive tumor size ≥5 cm determined pathologically.
    E.4Principal exclusion criteria
    • Participant has breast cancer with any of the following features:
    o Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
    o Lymph node-negative status
    o Pathological complete response (pCR) from any prior systemic treatments for early breast cancer
    o Inflammatory breast cancer
    • Participants with a history of previous breast cancer, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible.
    • The participant has previously received treatment with:
    o Any CDK4 and CDK6 inhibitor
    o Adjuvant treatment with immunotherapy, tucatinib, neratinib, investigational HER2 directed therapy, or DS8201 for treatment of breast cancer.
    o ET (i.e., tamoxifen, raloxifene or AI) for breast cancer prevention (without diagnosis of breast cancer).
    o Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care therapy for their breast cancer at study enrollment
    E.5 End points
    E.5.1Primary end point(s)
    To compare invasive disease free survival (IDFS) for abemaciclib plus physician’s choice ET versus placebo plus physician’s choice ET in the study population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After approximately 50 months from first participant randomized when approximately 324 IDFS events have occurred.
    E.5.2Secondary end point(s)
    • Efficacy endpoints: overall survival (OS), distant relapse-free survival (DRFS)
    • Safety endpoints, including but not limited to TEAEs, SAEs, hospitalizations, clinical laboratory tests, vital signs, and physical examinations
    • To evaluate participant-reported symptoms, function and global health status/QOL based on EORTC QLQ-C30 scales
    • To evaluate health status in the study population to inform decision modeling for health economic evaluation using the EQ-5D 5L index score
    • To evaluate the PK of abemaciclib based on abemaciclib concentrations
    E.5.2.1Timepoint(s) of evaluation of this end point
    After approximately 50 months from first participant randomized when approximately 324 IDFS events have occurred.
    At the end of trial.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA203
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    United States
    Austria
    Belgium
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Romania
    Spain
    Switzerland
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    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 years10
    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 years10
    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: 2205
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 245
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 757
    F.4.2.2In the whole clinical trial 2450
    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)
    After the on-study intervention period, standard adjuvant ET should continue for a duration of 3 to 8 additional years, for a total duration of up to 10 years, if deemed medically appropriate.
    Standard approved adjuvant ET is per physician’s choice (such as, tamoxifen or an aromatase inhibitor, with or without ovarian function suppression per standard practice).
    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 Decision2021-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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