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    Summary
    EudraCT Number:2020-005200-19
    Sponsor's Protocol Code Number:I-CONIC
    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:2020-12-18
    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 number2020-005200-19
    A.3Full title of the trial
    Use of Imatinib to convert triple negative breast cancer into ER-positive breast cancer - "I-CONIC"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imatinib for conversion of triple negative breast cancer into oesrogen dependent breast cancer - "I-CONIC"
    A.3.2Name or abbreviated title of the trial where available
    I-CONIC
    A.4.1Sponsor's protocol code numberI-CONIC
    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 SponsorVästra Götalandsregionen/Onkologiska kliniken
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Unit, Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden
    B.5.2Functional name of contact pointMrs Annika Baan
    B.5.3 Address:
    B.5.3.1Street AddressBlå Stråket 2
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number+46700906097
    B.5.5Fax number+4631823931
    B.5.6E-mailannika.baan@vgregion.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 Imatinib
    D.2.1.1.2Name of the Marketing Authorisation holderAccord, Actavis
    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 nameImatinib
    D.3.2Product code L01XE01
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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
    Early Triple Negative Breast Cancer planned for surgery.
    E.1.1.1Medical condition in easily understood language
    Early Triple Negative Breast Cancer planned for surgery (preoperative chemotherapy not indicated).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 determine the proportion of patients that convert from Triple Negative to oestrogen dependent breast cancer.
    E.2.2Secondary objectives of the trial
    Toxicity of short-term (10 days) treatment with imatinib.

    Exploratory analyses: Identification of predictive markers for conversion by evaluation of molecular characteristics (gene expression profiles, immune response, proliferation).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    • Histologically confirmed invasive primary triple negative breast cancer ≥15 mm with any node status.
    • Age ≥18 years old.
    • Triple negative subtype is defined below:
    o Hormone receptor status: the invasive tumour shall be ER- and PR-negative [staining present in <10% by immunohistochemistry (IHC)].
    o HER2 status: the invasive tumour shall be HER2-negative by the ASCO CAP guidelines
    • No previous systemic treatment for TNBC.
    • No concurrent anti-cancer treatment.
    • Treatment with Bisphosphonates may continue.
    • ECOG performance status 0-1
    • Normal organ function as defined below:
    o absolute white blood cell count ≥1.5 x 109/L
    o platelets ≥100 x 109/L
    o haemoglobin ≥90g/dL
    o total bilirubin ≤1.5 x institutional UNL/dL (≤ 3 x UNL for patients with Gilbert´s syndrome)
    o ASAT, ALAT, GGT and alkaline phosphatase levels < 1.5 × institutional ULN.
    o albumin >2.5mg/dL
    o Creatinine < 110 μmol/L
    o T3, T4 and TSH (only patients with previous thyroid dysfunction)
    • Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy.
    • Female patients of childbearing potential must agree to use contraceptive methods with a failure rate below 1% per year during the study treatment and at least 90 days after the last dose of imatinib.
    • Patients must be able to take (swallow) an oral medication.
    • Patients must be capable to understand and comply with the protocol and has signed the informed consent.
    E.4Principal exclusion criteria
    Exclusion criteria
    • HER2 positive or luminal (ER/PgR positive) breast cancer.
    • Concomitant treatment for breast cancer within 14 days before registration.
    • Unable to adhere to the study procedures.
    • Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
    • Pregnancy and breast feeding.
    • Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ and a cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence.
    • Known human immune deficiency positivity.
    • Known active Hepatitis B or Hepatitis C.
    E.5 End points
    E.5.1Primary end point(s)
    ER-positivity at surgery after pre-treatment with imatinib [time frame from base-line to surgery].
    ER is assessed according to the international guide-lines and by gene expression profiles.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From base-line biopsy to surgery [2 weeks]
    E.5.2Secondary end point(s)
    Toxicity and safety of short term exposure to imatinib [time frame 6 weeks]
    Side effects are assessed and graded according to the National Cancer Institute CTCAE version 5.

    Exploratory analyses (gene expression profiles including intrinsic subtypes, immune response, proliferation) in relation to proportion of patients in whom tumours are successfully converted to oestrogen dependent breast cancer.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity - from first dose of imatinib to 30 days after the last dose of imatinib [time frame 6 weeks].

    Exploratory analyses: Laboratory analyses will be completed within 6 months from the last dose of imatinib for the last included patient.
    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
    Window-of-opportunity trial. Patients will receive imatinib for 10 days before surgery. The primary end-point is the proportion of patients in whom the initially triple negative breast cancer is converted to oestrogen dependent breast cancer.
    No anti-tumoural effect is expected.
    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.8.1.7.1Other trial design description
    Window of opportunity trial
    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 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 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
    All laboratory analyses shall be completed within 6 months after the 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 months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state40
    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 completion of imatinib and surgery, patients will be adviced standard adjuvant treatment for their breast cancer according to the multi-diciplinary comference recommendation. It may include chemotherpay, targeted therapy and radiotherapy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Sahlgrenska University Hospital, Department of Oncology
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Sahlgrenska University Hospital, Department of Pathology
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Lunds University, Deparment of Laboratory Medicine
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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