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    Summary
    EudraCT Number:2017-002115-34
    Sponsor's Protocol Code Number:ABY-025-MI301
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-17
    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 number2017-002115-34
    A.3Full title of the trial
    A multicenter phase II/III-study of 68Ga-ABY-025 PET for non-invasive quantification of HER2-expression in advanced breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter phase II/III-study of 68Ga-ABY-025 PET for non-invasive quantification of HER2-expression in advanced breast cancer
    A.3.2Name or abbreviated title of the trial where available
    Affibody-3
    A.4.1Sponsor's protocol code numberABY-025-MI301
    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 SponsorRegion Uppsala
    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 supportRoche AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportAffibody AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportEckert&Ziegler AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportSwedish Cancer Society
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportBRO Breast Cancer Foundation
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJens Sörensen / PET center
    B.5.2Functional name of contact pointPET Information
    B.5.3 Address:
    B.5.3.1Street AddressPET center and department of nuclear medicine, Akademiska Sjukhuset
    B.5.3.2Town/ cityUppsala
    B.5.3.4CountrySweden
    B.5.6E-mailjens.sorensen@pet.uu.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 No
    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 nameABY-025 labelled with gallium-68
    D.3.2Product code [68Ga]ABY-025
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 Yes
    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
    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 PT
    E.1.2Classification code 10006187
    E.1.2Term 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 correlate the HER2-expression in tumors measured by 68Ga-ABY-025 PET to gold standard histopathology based on IHC-status and ISH-analyses.
    E.2.2Secondary objectives of the trial
    * To compare the HER2-expression in tumors measured by 68Ga-ABY-025 PET tumor to background ratio (TBR) to standardized uptake values (SUV).
    * Define optimal SUV and TBR cut-off values for separating metastatic HER2-status into HER2-negative and HER2-positive at 2, 3 and 4 hours in a subset of 40 patients.
    * To correlate the HER2-expression in tumors measured by 68Ga-ABY-025 PET standardized uptake values (SUV) to IHC-status and percentage of stained cells.
    * Study the intra-individual heterogeneity of HER2 expression (IHC and ISH) in patients with more than one metastasis ≥ 1cm.
    * Study the variability of HER2 expression (IHC and ISH) between primary tumor and metastases.
    * To study if the investigation with 68Ga-ABY-025 PET leads to changes in the proposed treatment and in which proportion of the examined patients this occur.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Signed written informed consent.
    * Age ≥18 years.
    * Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast.
    HER2-positive defined as:
    a. 3+ by immunohistochemistry [IHC] in >10% of cell areas.
    b. 2+ by IHC in >10% of cell areas and HER2/CEP17 ratio ≥2.0 or HER2 copy number ≥ 6.0 by in situ hybridization [ISH]).
    HER2-borderline positive defines as:
    c. 2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization [ISH]) (“equivocal”).
    d. 2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number <4.0 by in situ hybridization [ISH]) (“2+ ISH negative”).
    e. Known inhomogeneous HER2-expression in the primary tumor with HER2-positive areas <10% (“inhomogeneous”).
    * Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
    * At least one tumor lesion ≥ 10 mm.
    * At least one tumor lesion available for biopsy.
    * Newly diagnosed or confirmed progression and planned for therapy with trastuzumab emtansine or anti-HER2 targeted therapy(-ies) concomitant with chemotherapy (HER2-positive cohort) or chemotherapy (HER2-negative patients).
    * WHO performance status ≤ 2.
    * Predicted survival > 12 weeks
    E.4Principal exclusion criteria
    * Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
    * Other manifest malignancy.
    * Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.
    * Inadequate organ function, suggested by the following laboratory results:
    • Absolute neutrophil count <1,500 cells/mm3
    • Total bilirubin ≥1.5 x ULN (unless the patient has documented Gilbert’s syndrome)
    • AST (SGOT) or ALT (SGPT) >5.0 × ULN
    • Serum creatinine clearance <30 ml/min
    * Patients of childbearing potential and sexually active and not willing to use adequate contraceptive.
    * Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    To correlate the HER2-expression in tumors measured by 68Ga-ABY-025 PET to gold standard histopathology based on IHC-status and ISH-analyses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analysis year 2019, final analysis year 2021 (after end of study).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2018-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-02-05
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