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    Summary
    EudraCT Number:2018-002998-21
    Sponsor's Protocol Code Number:CLEE011O12301C
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-11
    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 number2018-002998-21
    A.3Full title of the trial
    A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)
    Étude de phase III, multicentrique, randomisée, ouverte, évaluant l'efficacité et la tolérance du ribociclib associé à l'endocrinothérapie en tant que traitement adjuvant chez des patients atteints d'un cancer du sein précoce positif aux récepteurs hormonaux, HER2 négatif (New Adjuvant TriAl with Ribociclib [LEE011] : NATALEE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with
    endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer
    Étude de phase III, multicentrique, randomisée, ouverte, évaluant l'efficacité et la tolérance du ribociclib associé à l'endocrinothérapie en tant que traitement adjuvant chez des patients atteints d'un cancer du sein précoce HR + / HER2
    A.4.1Sponsor's protocol code numberCLEE011O12301C
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03701334
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address2 et 4 rue Lionel Terray
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@novartis.com
    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 Kisqali
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameribociclib
    D.3.2Product code LEE011
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIBOCICLIB
    D.3.9.1CAS number 1374639-75-4
    D.3.9.2Current sponsor codeLEE011
    D.3.9.4EV Substance CodeSUB180246
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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 Femara
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma SAS
    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 nameletrozole
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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: 3
    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 Reseligo
    D.2.1.1.2Name of the Marketing Authorisation holderAlvogen IPCo S-àr.1
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 namegoserelin
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGOSERELIN
    D.3.9.1CAS number 65807-02-5
    D.3.9.4EV Substance CodeSUB07962MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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: 4
    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 STADA
    D.2.1.1.2Name of the Marketing Authorisation holderSTADApharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanastrozole
    D.3.9.1CAS number 120511-73-1
    D.3.9.3Other descriptive nameANASTROZOLE
    D.3.9.4EV Substance CodeSUB05502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    hormone receptor-positive, HER2-negative, early breast cancer
    cancer du sein précoce (CSP) positif aux récepteurs hormonaux (HR), HER2 négatif.
    E.1.1.1Medical condition in easily understood language
    early breast cancer
    cancer du sein précoce
    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 LLT
    E.1.2Classification code 10006203
    E.1.2Term Breast cancer stage unspecified
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare iDFS for ribociclib + ET versus ET in patients with HRpositive, HER2-negative, EBC
    Comparer l'IDFS pour le ribociclib + endocrinothérapie versus endocrinothérapie chez des patients atteints de CSP HR positif, HER2 négatif
    E.2.2Secondary objectives of the trial
    1. To evaluate the two treatment arms with respect to recurrence-free survival (RFS)
    2. To evaluate the two treatment arms with respect to distant diseasefree survival (DDFS)
    3. To evaluate the two treatment arms with respect to OS
    4. To evaluate patient reported outcomes (PRO) for health-related quality of life (QoL) in the two
    treatment arms
    5. To characterize the PK of ribociclib when given in combination with NSAI (and goserelin if applicable)
    1. Évaluer les deux bras de traitement au regard de la survie sans récidive (SSR)
    2. Évaluer les deux bras de traitement au regard de la survie sans maladie à distance (SSMD)
    3. Évaluer les deux bras de traitement au regard de la survie globale (SG)
    4. Évaluer les résultats rapportés par le patient (patient-reported outcomes, PRO) en termes de qualité de vie liée à la santé (QdVS) dans les deux bras de traitement
    5. Caractériser la pharmacocinétique (PK) du ribociclib administré en association avec un IANS (et la goséréline le cas échéant)” [= objective 6 in the French protocol summary)]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is ≥ 18 years-old at the time of PICF
    signature
    - Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant ET (whichever occurs earlier), or male.
    - Patient with histologically confirmed unilateral
    primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
    - Patient has breast cancer that is positive for ER
    and/or PgR
    - Patient has HER2-negative breast cancer
    - Patient has available archival tumor tissue from
    the surgical specimen
    - Patient after surgical resection where tumor was
    removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III)
    - If indicated, patient has completed adjuvant
    and/or neoadjuvant chemotherapy according to the
    institutional guidelines
    - If indicated, patient has completed adjuvant
    radiotherapy according to the institutional guidelines
    - Patient has no contraindication for the adjuvant
    ET in the trial and is planned to be treated with ET for 5 years
    - Patient(e) d'âge ≥ 18 ans au moment de la signature du FCE.
    - Femme ayant un statut ménopausique connu au moment de la signature du FCE ou de l'initiation de l'endocrinothérapie adjuvante (à la première de ces échéances), ou homme
    - Patient(e) ayant un adénocarcinome du sein primaire invasif unilatéral confirmé histologiquement, avec une date de diagnostic cytologique ou histologique initial dans les 18 mois précédant la randomization.
    - Patients ayant un cancer du sein positif pour les récepteurs ER et/ou PR selon la dernière analyse de tissu effectuée par le laboratoire local.
    - Patients ayant un cancer du sein HER2 négatif
    - Patients ayant un échantillon de tissu tumoral archivé disponible du prélèvement chirurgical, pour soumission à un laboratoire central.
    - Patients ayant subi une résection chirurgicale consistant en l'ablation de la totalité de la tumeur, avec des marges microscopiques sur les pièces de résection finale exemptes de tumeur (stade anatomique groupe II ou III)
    - Si indiqué, le patient a terminé l'adjuvant et / ou une chimiothérapie néoadjuvante selon le
    directives institutionnelles
    - Si indiqué, le patient a terminé l'adjuvant radiothérapie selon les directives de l'établissement
    - Patient(e) ne présentant pas de contre-indication à l'endocrinothérapie adjuvante dans l'étude et devant être traité(e) par endocrinothérapie pendant 5 ans (à compter de la date de randomisation) ou plus.
    E.4Principal exclusion criteria
    - Patient has received any CDK4/6 inhibitor
    - Patient has received prior treatment with
    tamoxifen, raloxifene or AIs for reduction in risk
    (“chemoprevention”) of breast cancer and/or
    treatment for osteoporosis within the last 2 years prior to PICF signature
    - Patient has received prior treatment with
    anthracyclines at cumulative doses of 450 mg/m² or
    more for doxorubicin, or 900 mg/m² or more for
    epirubicin.
    - Patient with a known hypersensitivity to any of
    the excipients of ribociclib and/or ET
    - Patient with distant metastases of breast cancer
    beyond regional lymph nodes (stage IV according to
    AJCC 8th edition) and/or evidence of recurrence after curative surgery.
    - Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
    - Patient has had major surgery, chemotherapy or
    radiotherapy within 14 days prior to randomization
    - Patient has not recovered from clinical and
    laboratory acute toxicities related to prior anti-cancer therapies
    - Patient has a concurrent invasive malignancy or
    a prior invasive malignancy whose treatment was
    completed within 2 years before PICF signature
    - Patient has known HIV infection, Hepatitis B or C
    infection
    - Clinically significant, uncontrolled heart disease
    and/or cardiac repolarization abnormality
    - Patient:
    - is currently receiving any of the following substances within 7 days before randomization - Concomitant
    medications, herbal supplements, and/or
    fruits that are known as strong inhibitors or inducers of
    CYP3A4/5 or Medications that have a narrow
    therapeutic window and are predominantly
    metabolized through CYP3A4/5
    - is currently receiving or has received systemic
    corticosteroids ≤ 2 weeks prior to starting trial
    treatment
    - Patient has impairment of GI function or GI disease
    that may significantly alter the absorption of the oral
    trial treatments
    - Patient has any other concurrent severe and/or
    uncontrolled medical condition that would, in the
    Investigator’s judgment, cause unacceptable safety
    risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
    - Patient participated in another interventional study
    and received treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
    - Pregnant or breast-feeding (lactating) women or
    women who plan to become pregnant or breast-feed during the trial.

    additional exclusion criteria as per full protocol may apply.
    - Patient(e) ayant reçu un inhibiteur de CDK4/6.
    - Patient(e) ayant reçu un traitement antérieur par tamoxifène, raloxifène ou IA pour la réduction du risque (« chimioprévention ») de cancer du sein et/ou le traitement de l'ostéoporose au cours des deux années
    précédant la signature du FCE.
    - Patient(e) ayant reçu un traitement antérieur par anthracyclines à doses cumulatives de 450 mg/m² ou plus pour la doxorubicine, ou de 900 mg/m² ou plus pour l'épirubicine.
    - Patient(e) ayant une hypersensibilité connue à l'un des excipients du ribociclib et/ou de l'endocrinothérapie (problèmes héréditaires rares d'intolérance au galactose, déficience en lactase de Lapp,
    malabsorption du glucose-galactose, et allergie au soja).
    - Patient(e) ayant des métastases distantes du cancer du sein au-delà des ganglions lymphatiques régionaux (stade IV selon la classification AJCC, 8ème édition) et/ou des signes de récidive après chirurgie curative.
    - Patient(e) recevant simultanément un autre traitement antinéoplasique, en dehors de l'endocrinothérapie adjuvante (voir critère d'inclusion n°Error! Reference source not found.).
    - Patient(e) ayant reçu une chirurgie majeure, une chimiothérapie ou une radiothérapie dans les 14 jours précédant la randomisation.
    - Patient(e) n'ayant pas récupéré de toxicités aiguës cliniques et biologiques associées à de précédentes thérapies anticancéreuses.
    - Patient(e) ayant un cancer invasif concomitant ou un cancer antérieur dont le traitement s'est achevé dans les deux ans précédant la signature du FCE.
    - Patient(e) ayant des antécédents connus d'infection par le virus de l'immunodéficience humaine (VIH) (le dépistage n'est pas obligatoire).
    - Patient(e) ayant une infection active établie par le virus de l'hépatite B (VHB) ou de l'hépatite C (VHC) (le dépistage n'est pas obligatoire).
    - Maladie cardiaque non contrôlée cliniquement significative et/ou trouble de la repolarisation cardiaque
    - Patient(e) recevant actuellement l'une des substances suivantes dans
    les 7 jours précédant la randomisation :
     Médicaments concomitants, suppléments à base de plantes et/ou fruits (pamplemousse, pomelos, carambole, oranges de Séville) et leurs jus connus pour être de puissants inhibiteurs ou inducteurs du CYP3A4/5
     Médicaments à marge thérapeutique étroite et essentiellement
    métabolisés par le CYP3A4/5
    - Patient(e) recevant actuellement ou ayant reçu des corticoïdes systémiques dans un délai ≤ 2 semaines avant l'initiation du traitement de l'étude, ou n'ayant pas complètement récupéré des effets secondaires de ce traitement.
    - Patient(e) souffrant d'une altération de la fonction gastro-intestinale (GI) ou d'une maladie GI susceptible d'altérer significativement l'absorption des traitements oraux de l'étude (maladies ulcératives non contrôlées,
    nausées non contrôlées, vomissements ou diarrhées, syndrome de malabsorption, ou résection de l'intestin grêle).
    - Patient(e) présentant toute autre affection médicale concomitante sévère et/ou non contrôlée qui, de l'avis de l'investigateur, induirait des risques inacceptables pour la sécurité du patient, contre-indiquerait la participation à l'étude ou compromettrait l'observance du protocole (pancréatite chronique, hépatite active chronique, cirrhose du foie ou toute autre maladie hépatique significative, infection fongique, bactérienne ou virale active non traitée ou non contrôlée, infection active requérant un traitement antibactérien systémique, etc.), ou limiterait l'espérance de vie à une durée ≤ 5 ans.
    - Patient(e) ayant participé à une autre étude interventionnelle et ayant reçu un traitement avec un produit expérimental (ou ayant utilisé un dispositif expérimental) dans les 30 jours précédant la randomisation
    ou dans les 5 demi-vies du produit expérimental, à la plus longue deces échéances.
    - Femme enceinte ou allaitante ou femme envisageant de tomber enceinte ou d'allaiter pendant l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    iDFS using STEEP criteria, as assessed by Investigator
    IDFS selon les critères STEEP, évaluée par l'investigateur
    E.5.1.1Timepoint(s) of evaluation of this end point
    3.5 years
    3.5 ans
    E.5.2Secondary end point(s)
    - recurrence free survival (RFS) using STEEP criteria
    (Standardized Definitions for Efficacy End Points in
    Adjuvant Breast Cancer Trials)
    - Distant disease free survival (DDFS) using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)
    - overall survival (OS)
    - Change from baseline in the physical functioning subscale score and global health status/Quality of life scale score as assessed by EORTC QLQ-C30
    - PK parameters such as Cmax, Tmax, and AUC0- 24h for ribociclib
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 3.5 years
    - 3.5 years
    - 7.5 years
    - 3.5 years
    - 3.5 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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
    - Quality of life (QoL) and patient reported outcomes (PRO)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned34
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA201
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    China
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Peru
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    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
    end of trial will be declared when 60 months + 30 days have elapsed from the date the last patient has been randomized
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial days4
    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: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 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 state266
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1764
    F.4.2.2In the whole clinical trial 4000
    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)
    endocrine therapy or any other anti-cancer treatment according to investigator's clinical judgement
    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 Decision2019-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-12
    P. End of Trial
    P.End of Trial StatusOngoing
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