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    Summary
    EudraCT Number:2019-001463-75
    Sponsor's Protocol Code Number:ICO-2019-04
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001463-75
    A.3Full title of the trial
    Pilot Feasibility Study: Inflammation and presence of M2 macrophages explorations with[18F]-DPA-714 PET/CT in Triple Negative breast cancers
    Étude Pilote de faisabilité : Exploration par TEP/TDM au [18F]-DPA-714 de l’inflammation et de la présence de macrophages M2 dans les cancers du sein Triple Négatif
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inflammation and presence of M2 macrophages explorations with[18F]-DPA-714 PET/CT in Triple Negative breast cancers
    Exploration par TEP/TDM au [18F]-DPA-714 de l’inflammation et de la présence de macrophages M2 dans les cancers du sein Triple Négatif
    A.3.2Name or abbreviated title of the trial where available
    EITHICS
    EITHICS
    A.4.1Sponsor's protocol code numberICO-2019-04
    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 SponsorINSTITUT DE CANCEROLOGIE DE L'OUEST
    B.1.3.4CountryFrance
    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 supportICO
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSIRIC ILIAD
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT DE CANCEROLOGIE DE L'OUEST
    B.5.2Functional name of contact pointPACTEAU- DRCI
    B.5.3 Address:
    B.5.3.1Street AddressBD JACQUES MONOD
    B.5.3.2Town/ citySAINT HERBLAIN
    B.5.3.4CountryFrance
    B.5.4Telephone number+332 40 67 99 08
    B.5.5Fax number+332 40 67 97 87
    B.5.6E-maildrci@ico.unicancer.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDPA-714
    D.3.2Product code DPA-714
    D.3.4Pharmaceutical form Concentrate for 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 No
    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
    Patients with Triple Negative Breast Cancer prior to surgical treatment
    Patientes présentant un cancer du sein Triple Négatif avant une prise en charge chirurgicale d’emblée.
    E.1.1.1Medical condition in easily understood language
    Patients with Triple Negative Breast Cancer prior to surgical treatment
    Patientes présentant un cancer du sein Triple Négatif avant une prise en charge chirurgicale d’emblée.
    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 10075566
    E.1.2Term Triple negative 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
    Study of correlations between tumor immunohistochemical analysis (IHC) and in vivo [18F]-DPA-714 PET/TDM analysis for detection of M2 macrophages infiltrating breast cancer tumor Triple Negative
    Etude des corrélations entre l’analyse immunohistochimique (IHC) de la tumeur et l’analyse in vivo par la TEP/TDM au [18F]-DPA-714 pour la détection des macrophages M2 infiltrant la tumeur des cancers du sein Triple Négatif.
    E.2.2Secondary objectives of the trial
    • Determine the correlation between TSPO genotyping (HAB, MAB and LAB) and [18F]DPA-714 PET/TDM binding in TN breast cancer
    • Assess the value of the early and late times of [18F]-DPA-714 PET/CT acquisitions.
    • Evaluate the performance of the three types of imaging used in this study: [18F] -DPA-714 PET / CT (early and late), 18FDG PET / CT and breast MRI in the characterization of Triple breast cancers.
    • Characterization of Triple Negative Breast Cancer.
    • Evaluate the potential toxicity of [18F] -DPA-714.
    •Déterminer la corrélation entre le génotypage de la TSPO (HAB, MAB et LAB) et la fixation à la TEP/TDM avec le traceur [18F]DPA-714 dans le cancer du sein TN.
    •Evaluer l’intérêt des temps précoce et tardif de l’acquisition de la TEP/TDM au [18F]-DPA-714.
    •Evaluer les performances des trois types d’imageries utilisées dans cette étude : la TEP/TDM au [18F]-DPA-714 (précoce et tardive), la TEP/TDM au 18FDG et celle de l’IRM de diffusion mammaire dans la caractérisation des cancers du sein Triple.
    •Caractérisation du cancer du sein Triple Négatif.
    •Evaluer la toxicité éventuelle du [18F]-DPA-714.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria






    1. Patient over the age of 18
    2. Patient with Triple Negative Breast Cancer defined according to the following criteria:
    - Estrogen receptors <10%
    - and progesterone receptors <10%
    - And HER2 not amplified or not overexpressed
    3. Patient with a primary tumor having a primary surgery indication
    4. PS 0 or 1
    5. Effective contraception in women of childbearing age
    1.Patiente âgée de plus de 18 ans
    2.Patiente présentant un cancer du sein Triple Négatif défini selon les critères suivants :
    -Récepteurs aux oestrogènes < 10%
    -Et Récepteurs progestérone < 10%
    -Et HER2 non amplifié ou non surexprimé
    3.Patiente avec une tumeur primitive ayant une indication de chirurgie première
    4.PS 0 ou 1
    5.Contraception efficace chez les femmes en âge de procréer
    E.4Principal exclusion criteria
    1. Patient with non-triple negative breast cancer
    2. Patient with inflammatory breast cancer
    3. Patient with metastatic breast cancer
    4. Patient receiving anti-cancer treatments such as chemotherapy, immunotherapy, biological response modifiers, hormone therapy and radiotherapy BEFORE biopsy and PET examinations
    5. Treated diabetes with fasting glucose > 10 mmol / L
    6. Patient who received antibiotics and / or steroidal and / or nonsteroidal anti-inflammatory drugs within 30 days BEFORE [18F] - DPA-714 PET/CT
    7. Contraindication to performing an MRI (implants or metal prosthesis, severe claustrophobia, pacemaker ...)
    8. Contraindication to injection of iodinated contrast media
    9. Patient deprived of liberty or placed under the authority of a guardian
    10. Pregnant woman, likely to be pregnant or breastfeeding
    11. Agitation, impossibility of lying motionless for at least 1 hour, or known claustrophobia.
    1.Patiente présentant un cancer du sein NON triple négatif
    2.Patiente présentant un cancer du sein inflammatoire
    3.Patiente présentant un cancer du sein métastatique
    4.Patiente recevant des traitements anti-cancéreux tels que la chimiothérapie, l'immunothérapie, les modificateurs de la réponse biologique, l'hormonothérapie et la radiothérapie AVANT la réalisation de la biopsie et des examens par TEP
    5.Diabète traité avec une glycémie à jeun > 10 mmol/L
    6.Patiente ayant reçu des antibiotiques et/ou des anti-inflammatoires stéroïdiens et/ou non stéroïdiens dans les 30 jours AVANT la TEP au [18F]-DPA-714
    7.Contre-indication à la réalisation d’une IRM (implants ou prothèse métallique, claustrophobie sévère, pacemaker …)
    8.Contre-indication à l’injection de produits de contraste iodés
    9.Patiente privée de liberté ou placée sous l'autorité d'un tuteur
    10.Femme enceinte, susceptible de l’être ou en cours d'allaitement
    11.Agitation, impossibilité de tenir allongé immobile au moins 1 heure, ou claustrophobie connus.
    E.5 End points
    E.5.1Primary end point(s)
    positive (VPP) and negative (NPV) predictive values ​​of [18F] -DPA-714 PET / CT for the detection of M2 macrophage activity in the
    Valeurs prédictives positive (VPP) et négative (VPN) de la TEP/TDM au [18F]-DPA-714 pour la détection de l’activité macrophagique M2 au sein de la tumeur.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 month after TEP-DPA714
    3 mois après la TEP DPA714
    E.5.2Secondary end point(s)
    • Genotyping of TSPO will be done at the end of the study. The results will be compared to the [18F] DPA-714 PET / CT binding data
    • The comparison of early and late [18F] -DPA-714 PET / CT acquisitions will be done by comparing the qualitative and quantitative parameters of both acquisitions
    • Comparison of [18F] -DPA-714 PET / CT performance with 18FDG PET / CT and mammary diffusion MRI in TN breast cancer characterization with texture of images analysis
    • Characterization of the tumor will be achieved through the use of an antibody panel in immunohistochemistry on the specimen.
    • The toxicity of [18F] -DPA-714 will be ckecked by vital signs and patient monitoring for two hours following radiopharmaceutical injection. Any toxicity related to [18F] -DPA-714 will be reported. The reference NCI Common Toxicity Criteria, version 5.0 will be used (Annex 5).
    •Le génotypage de la TSPO sera réalisé en fin d’étude. Les résultats seront confrontés aux données de la fixation à la TEP/TDM au [18F]DPA-714.
    •La comparaison des acquisitions TEP/ TDM [18F]-DPA-714 précoce et tardive se fera en confrontant les paramètres qualitatifs et quantitatifs des 2 acquisitions.
    •La comparaison des performances de la TEP/TDM au [18F]-DPA-714 avec celles de la TEP/TDM au 18FDG et celles de l’IRM mammaire de diffusion dans la caractérisation des cancers du sein TN sera réalisée grâce à des analyses de texture des images.
    •La caractérisation de la tumeur sera réalisée grâce à l’utilisation d’un panel d’Anticorps en immuno-histochimie sur la pièce opératoire.
    •La tolérance du [18F]-DPA-714 sera vérifiée par la mesure des signes vitaux et la surveillance du patient pendant deux heures suivant l'injection du radiopharmaceutique. Toute toxicité liée au [18F]-DPA-714 sera reportée. La référence NCI Common Toxicity Criteria, version 5.0 sera utilisée (annexe 5).
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 month after TEP-DPA714
    3 mois après la TEP DPA714
    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
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 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 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 state12
    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 Decision2019-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-21
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