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    Summary
    EudraCT Number:2013-000551-41
    Sponsor's Protocol Code Number:IMPACT_Breast_6.3
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000551-41
    A.3Full title of the trial
    Towards patient tailored cancer treatment supported by molecular imaging
    IMPACT: IMaging PAtients for Cancer drug selecTion – Metastatic Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging patients for cancer drug selection - metastatic breast cancer
    A.4.1Sponsor's protocol code numberIMPACT_Breast_6.3
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportAlpe d’HuZes grant/Dutch Cancer Society
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointDr. C. P. Schröder
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503612821
    B.5.5Fax number+31503614862
    B.5.6E-mailc.p.schroder@umcg.nl
    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 name89Zr-SUCDF-trastuzumab
    D.3.2Product code none
    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 INN89Zr-sucDF-trastuzumab
    D.3.9.1CAS number none
    D.3.9.2Current sponsor codenone
    D.3.10 Strength
    D.3.10.1Concentration unit Ci/mg curie(s)/milligram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.00002 to 0.0001
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.IMP: 2
    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 name16-alpha-[18F]-17-beta-estradiol
    D.3.2Product code 18F-FES
    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 INN16-alpha-[18F]-17-beta-estradiol
    D.3.9.1CAS number none
    D.3.9.2Current sponsor codenone
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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
    Metastatic Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Cancer
    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
    The primary objective is to evaluate the clinical utility of experimental PET scans, in the setting of MBC at first presentation. These scans include 18F-FES-PET and 89Zr-trastuzumab-PET scans at baseline, and 18F-FDG-PET for early response measurement.
    E.2.2Secondary objectives of the trial
    Secondary objectives are: a) Relation of experimental PET scans (baseline 18F-FES-PET and 89Zr-trastuzumab-PET; 18F-FDG-PET scan after 2 weeks for early response evaluation) to (progression free) survival. b) Relation of DNA sequencing, RNA expression analysis (including microRNA [miRNA] analysis) and kinome profiling of the biopsy and venous blood, of CTC count and ER/HER2 status of CTCs, as well as circulating tumor DNA to all imaging (standard and experimental), and clinical follow-up data (treatment response and survival). c) Assessment of molecular characteristics (pathological examination and molecular analysis) of primary biopsy, new baseline biopsy of a metastasis and (optional) biopsy taken during treatment and relation to all molecular, imaging (standard and experimental) and clinical follow up data (treatment response and survival). d) Assessment of cost-effectiveness of experimental PET scans. e) Quality of life assessment before and during therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
    2. Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
    •no recent (< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
    •in case of liver metastases: no significant (>50%) increase in liver function tests ASAT and ALAT in 2 weeks prior to screening visit.
    3. Patients in whom standard imaging work-up of MBC was recently (≤ 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
    4. Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
    5. Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
    6. Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the UMCG.
    7. WHO performance status 0-2.
    8. Patient is able to undergo PET imaging procedures.
    9. Age >18 years of age, willing and able to comply with the protocol as judged by the investigator.
    10. Signed written informed consent.
    E.4Principal exclusion criteria
    1. Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
    2. Pregnant or lactating women.
    3. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
    4. Inability to comply with study procedures.
    5. Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
    E.5 End points
    E.5.1Primary end point(s)
    In patients with measurable disease: treatment response on CT at 8 weeks (day 56 ± 3), according to RECIST1.1 criteria (both per patient and per metastasis). In patients with (non-measurable) bone metastases only, clinical response to treatment: progressive disease is defined as substantial worsening of overall complaints, meriting discontinuation of therapy. (Non-)response is related to baseline 18F-FES-PET and 89Zr-trastuzumab-PET (both per patient and per metastasis analysis); and 18F-FDG-PET at 2 weeks of treatment (both per patient and per metastasis analysis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks (56 +/- 3 days) after treatment start
    E.5.2Secondary end point(s)
    - The relation between progression free survival (PFS, defined as time from start of treatment until moment of documented tumor progression or death) to either positive or negative baseline 18F-FES-PET, 89Zr-trastuzumab-PET and 2 week 18F-FDG-PET.
    - The relation between DNA sequencing and RNA expression analysis (including miRNA analysis) of the biopsy and venous blood samples to all molecular, imaging (standard and experimental) and clinical follow-up data (treatment response and survival).
    - The relation between miRNA analysis of the baseline biopsy and a venous blood sample at baseline, and all other molecular, imaging and clinical follow-up data.
    - The relation between peptide profiling of new baseline biopsy and venous blood samples (baseline and day of standard response assessment) and all other molecular, imaging and clinical follow-up data.
    - The assessment of molecular changes of primary biopsy, new baseline biopsy and (optional) biopsy taken during treatment and the relation to all other molecular, imaging and clinical follow up data.
    - The relation between CTC count and ER/HER2 status of CTCs at baseline and all molecular findings of the available biopsies (primary, baseline and, if feasible later biopsies) and venous blood samples, all imaging and clinical follow-up data.
    - The assessment of circulating tumor DNA analysis at baseline, day of early 18F-FDG-PET and standard response assessment to the molecular findings of the available biopsies and venous blood samples, as well as to all imaging and clinical follow-up data.
    - The relation between peptide profiling of the baseline biopsy and venous blood samples (baseline and day of standard response assessment), and all other molecular, imaging and clinical follow-up data.
    - The relation between circulating miRNA analysis (baseline) and all other molecular, imaging and clinical follow-up data.
    - The quantification of the cost-effectiveness of the experimental imaging (baseline 18F-FES-PET and 89Zr-trastuzumab-PET; 2 week 18F-FDG-PET) as described in paragraph 7.4.6.
    - The assessment of patients’ QoL before and during treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of inclusion
    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 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 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) 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 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 concerned3
    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 years3
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with metastatic disease
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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)
    Best routine care.
    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 Decision2014-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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