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    Summary
    EudraCT Number:2020-003575-18
    Sponsor's Protocol Code Number:ICO-2020-06
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-003575-18
    A.3Full title of the trial
    Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
    Impact de l’Hormonothérapie Neoadjuvante sur la prise en charge chirurgicale des carcinomes canalaires in Situ étendus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
    Impact de l’Hormonothérapie Neoadjuvante sur la prise en charge chirurgicale des carcinomes canalaires in Situ étendus
    A.3.2Name or abbreviated title of the trial where available
    HORNEO 01
    A.4.1Sponsor's protocol code numberICO-2020-06
    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 supportDGOS-INCa PHARC-K 19-087
    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 pointPROMOTION - DRC
    B.5.3 Address:
    B.5.3.1Street AddressBD JACQUES MONOD
    B.5.3.2Town/ citySAINT HERBLAIN
    B.5.3.4CountryFrance
    B.5.4Telephone number33240679747
    B.5.5Fax number33240679787
    B.5.6E-mailpromotionrc@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 Yes
    D.2.1.1.1Trade name tamoxifene
    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 nametamoxifene
    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.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 Yes
    D.2.1.1.1Trade name anastrozole
    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 nameanastrozole
    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
    Patients with extensive ductal carcinoma in situ with an indication for total mastectomy
    Patientes atteintes d’un Carcinome Canalaire in Situ (CCIS) étendu avec une indication d’une mastectomie totale
    E.1.1.1Medical condition in easily understood language
    Patients with extensive ductal carcinoma in situ with an indication for total mastectomy
    Patientes atteintes d’un Carcinome Canalaire in Situ (CCIS) étendu avec une indication d’une mastectomie totale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10006189
    E.1.2Term Breast cancer in situ
    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
    Demonstrate the efficacy of neoadjuvant hormone therapy in patients with extensive CCIS in order to propose conservative surgery after 6 months of treatment as an alternative to mastectomy, routinely performed in this indication.
    Démontrer l’efficacité de l'hormonothérapie néoadjuvante chez les patientes atteintes d’un CCIS étendu afin de proposer une chirurgie conservatrice après 6 mois de traitement comme alternative à la mastectomie, systématiquement réalisée dans cette indication.
    E.2.2Secondary objectives of the trial
    a) Evaluate the impact of neoadjuvant hormone therapy on dimension along the largest axis observed on MRI after 3 months and 6 months of hormone therapy treatment ;
    b) Evaluate recurrence-free survival at 5 and 10 years post-surgery;
    c) Evaluate overall survival at 5 and 10 years post-surgery;
    d) To identify immunological and histological predictors of tumor response to neoadjuvant hormone therapy after 6 months of hormone therapy ;
    e) To evaluate the impact of neoadjuvant hormone therapy on the presence of an infiltrating contingent found on the surgical specimen after 6 months of hormone therapy.
    f) Evaluate the evolution of the quality of life in the 10 years following surgery, according to the type of surgery (mastectomy or conservative surgery), and according to socio-demographic and psychological factors (anxiety, depression).
    a) Evaluer l’impact de l’hormonothérapie néoadjuvante sur la dimension selon le plus grand axe observé à l’IRM après 3 mois et 6 mois de traitement par hormonothérapie ;
    b) Evaluer la survie sans récidive à 5 ans et 10 ans post-chirurgie ;
    c) Evaluer la survie globale à 5 ans et 10 ans post-chirurgie ;
    d) Identifier les facteurs prédictifs immunologiques et histologiques de la réponse tumorale à l’hormonothérapie néoadjuvante après 6 mois d’hormonothérapie ;
    e) Evaluer l’impact de l’hormonothérapie néoadjuvante sur la présence d’un contingent infiltrant retrouvée sur la pièce chirurgicale après 6 mois d’hormonothérapie.
    f) Evaluer l’évolution de la qualité de vie dans les 10 ans suivant la chirurgie, selon le type de chirurgie (mastectomie ou chirurgie conservatrice), et selon les facteurs socio-démographiques et les facteurs psychologiques (anxiété, dépression).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Elderly patient ≥ 40 years old
    2) Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
    3) Clinical T0N0
    4) Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
    5) Indication for mastectomy
    6) CCIS visible on MRI performed with clip sequence
    7) Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.
    8) Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.
    9) Affiliated patient or beneficiary of the social security system.
    1) Patiente âgée ≥ 40 ans
    2) Diagnostic histologique de carcinome canalaire in situ sans contingent infiltrant
    3) T0N0 clinique
    4) Récepteurs oestrogènes positifs (RO+) quel que soit le statut des récepteurs progestérone (RP)
    5) Indication de mastectomie
    6) CCIS visible à l’IRM réalisée avec séquence clip
    7) Méthode de contraception efficace pour les femmes en âge de procréer ayant une activité sexuelle déclarée
    8) Information de la patiente et obtention du consentement libre, éclairé et écrit, signé par la patiente et l’investigateur
    9) Patiente affiliée ou bénéficiaire du régime de sécurité sociale.
    E.4Principal exclusion criteria
    1) Invasive breast carcinoma
    2) Lobular carcinoma in situ
    3) pN+ patient
    4) Indication for conservative surgery
    5) Contraindications to anastrozole or tamoxifen
    6) Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.
    7) Histologically proven multifocal lesion
    8) Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)
    9) History of homolateral breast cancer
    10) Ongoing contralateral breast cancer
    11) Known mutation BRCA1 BRCA2
    12) Other cancer in progress at inclusion
    13) Pregnant woman, or breastfeeding,
    14) Persons deprived of liberty or under guardianship or trusteeship,
    15) Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
    1) Carcinome mammaire infiltrant
    2) Carcinome lobulaire in situ
    3) Patiente pN+
    4) Indication de chirurgie conservatrice
    5) Contre-indications à l'anastrozole ou au tamoxifène
    6) Traitements concomitants pouvant interagir et réduire l’efficacité du tamoxifène par interaction avec le cytochrome CYP2D6
    7) Lésion multifocale prouvée histologiquement
    8) Contre-indication à l’IRM mammaire (pace maker, valve cardiaque, implant métallique, stimulateur neuronal ou périphérique, claustrophobie sévère, …)
    9) Antécédent de cancer du sein homolatéral
    10) Cancer du sein controlatéral en cours
    11) Mutation connue BRCA1 BRCA2
    12) Autre cancer en cours à l’inclusion
    13) Femme enceinte, ou en cours d'allaitement,
    14) Personnes privées de liberté ou sous tutelle ou sous curatelle,
    15) Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales, psychiques ou psychiatriques.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of neoadjuvant hormone therapy will be evaluated by the % of conservative surgeries performed after 6 months of treatment.
    L’efficacité de l’hormonothérapie néoadjuvante sera évaluée par le % de chirurgies conservatrices réalisées après 6 mois de traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month
    6 mois
    E.5.2Secondary end point(s)
    a) Variations du diamètre de la lésion cible selon le plus grand axe (antéro-postérieure, interne-externe ou supérieure-inférieure) observé à partir de l’IRM, avant traitement, après 3 mois et après 6 mois d’hormonothérapie ;
    b) Taux de survie sans récidive à 5 ans et à 10 ans post-chirurgie ;
    c)T aux de survie globale à 5 ans et à 10 ans post-chirurgie ;
    d) Variations du diamètre de la lésion cible selon le plus grand axe (antéro-postérieure, interne-externe ou supérieure-inférieure) observé à partir de l’IRM, avant traitement, après 3 mois et après 6 mois d’hormonothérapie selon les facteurs immunologiques et histologiques de la macrobiopsie ;
    e) % de contingent infiltrant retrouvé sur la pièce chirurgicale après 6 mois d’hormonothérapie ;
    f) Qualité de vie :
     Questionnaire SF-36 à l’inclusion, à 6 et 12 mois post-chirurgie puis tous les ans pendant 9 ans.
     Questionnaire EORTC QLQ-C30 à l’inclusion, à 6 et 12 mois post-chirurgie puis tous les ans pendant 4 ans.
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) & d) & e) 3 month - 6 month
    b) & c) & f) 5 and 10 years
    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 No
    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) 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 concerned8
    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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    E.8.9.1In the Member State concerned months
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 202
    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 state262
    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 Decision2020-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-09-26
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