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    Summary
    EudraCT Number:2014-004112-11
    Sponsor's Protocol Code Number:C/31/2014
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-04-21
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2014-004112-11
    A.3Full title of the trial
    ALERT: A phase II study of alternating eribulin and hormonal therapy in pre-treated ER+ve breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to look at the safety and possible benefit, of alternating the drug eribulin with an Aromatase Inhibitor, in patients with pre-treated oestrogen receptor positive (ER+ve) breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    ALERT
    A.4.1Sponsor's protocol code numberC/31/2014
    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 SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAction Against Cancer
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointHanna Nicholas
    B.5.3 Address:
    B.5.3.1Street AddressImperial Clinical Trials Unit – Cancer
    B.5.3.2Town/ cityMedical Oncology, Charing Cross Hospital
    B.5.3.3Post codeW6 8RF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442033117743
    B.5.6E-mailalert@imperial.ac.uk
    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 Halaven
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Europe Ltd.
    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 nameHALAVEN
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEribulin
    D.3.9.1CAS number 253128-41-5
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,44
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with locally advanced or metastatic oestrogen receptor positive (ER+ve) breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting.
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    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 assess the efficacy of Eribulin when prescribed in alternating cycles with an Aromatase Inhibitor (AI) in patients with locally advanced or metastatic breast cancer, based on progression free survival (PFS).
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of Eribulin when prescribed in alternating cycles with an Aromatase Inhibitor (AI) in patients with locally advanced or metastatic breast cancer, based on clinical benefit rate (CBR).
    • To assess the safety and tolerability of eribulin when prescribed in alternating cycles with an AI in patients with locally advanced or metastatic breast cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to admission to this study
    2. Aged 18≥over
    3. Histologically confirmed ER positive metastatic breast cancer according to
    local criteria.
    4. ECOG performance status 0 – 2
    5. Have progressed after at least one hormonal therapy regime and at least one
    chemotherapy regime for advanced disease
    6. Patients must have had prior treatment with an anthracycline and a taxane
    (either sequential or in combination) unless patients weren’t suitable for
    these treatments. This treatment can be in the adjuvant setting
    7. Measurable sites of locally advanced and/or metastatic disease that can be
    accurately assessed by CT/MRI scan at baseline (RECIST v1.1)¹
    8. Life expectancy of ≥6 months
    9. Adequate organ function, as defined by:
    • Haemoglobin (Hb) ≥9g/dL
    • Absolute Neutrophil Count (ANC) ≥1.5x109/L
    • Platelet count (Plts) ≥100x109/L
    • White Blood Cell (WBC) ≥3.0 x 109/L
    • Serum albumin ≤ 1.5 ULN
    • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN
    if no demonstrable liver metastases or ≤ 5 x ULN in the presence of liver
    metastases.
    • ALP ≤ 5 x ULN
    • Total bilirubin ≤ 1.5 x ULN if no demonstrable liver metastases or ≤ 3 x ULN in
    the presence of liver metastases
    • Creatinine ≤ 1.5 x ULN or creatinine clearance >50ml/min
    10. Postmenopausal as defined by age >50, no menstruation for >2 years, previous
    oophorectomy or lab results confirming this status
    11. Premenopausal if has been subject to ovarian ablation/ suppression at least 3
    weeks prior to commencing AI therapy

    ¹RECIST v1.1 updated and now considers bone metastasis with an identifiable soft tissue mass to be measurable disease. Therefore, patients with bone metastasis are eligible, provided they have evaluable disease.
    E.4Principal exclusion criteria
    1. Triple negative or HER2 positive cancer
    2. Hypersensitivity to the active substance or to any of its excipients
    3. History of another primary malignancy within 5 years prior to starting study
    treatment, except adequately treated basal or squamous cell carcinoma of the
    skin, carcinoma in site and the disease under study
    4. Evidence of uncontrolled active infection
    5. Severe hepatic impairment (Child-Pugh C)
    6. Evidence of significant medical condition or laboratory finding which, in the
    opinion of the Investigator, makes it undesirable for the patient to
    participate in the trial
    7. Concurrent therapy with any other investigational agent or everolimus
    8. Concomitant use within 14 days prior to commencement of study treatment of any
    investigational agent
    9. Uncontrolled abnormalities of serum potassium, sodium, calcium (corrected)
    phosphate or magnesium levels
    10. Pregnant or lactating women. Effective non-hormonal contraception is
    mandatory for all patients of reproductive potential
    11. Evidence of ovarian activity
    12. Prior eribulin therapy
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS), as assessed by RECIST v1.1 at 3, 6 and 9 months, defined as time from study entry to first evidence of disease progression or death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6 and 9 months
    E.5.2Secondary end point(s)
    • Clinical Benefit Rate (CBR),as assessed by RECIST v1.1 at 3, 6 and 9 months,
    defined as duration of complete response (CR), partial response (PR) and stable
    disease (SD) for 6 months or longer.
    • Safety and tolerability as assessed by adverse events according to the Common
    Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • CBR: 3, 6 and 9 months
    • Safety and tolerability: from first dose of IMP to 4 weeks after completion of
    study 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 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
    Biomarkers
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Following participation in the study, patient care will be decided by their local doctor according to usual practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-07-24
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