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    Summary
    EudraCT Number:2018-003553-19
    Sponsor's Protocol Code Number:IBCSG59-19/BIG18-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-003553-19
    A.3Full title of the trial
    A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
    Estudio de fase III, abierto, multicéntrico y aleatorizado de palbociclib como tratamiento adyuvante combinado con hormonoterapia en comparación con hormonoterapia sola en pacientes con recidiva locorregional aislada de cáncer de mama extirpado con receptor hormonal positivo y HER2 negativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical trial, which tests the safety and efficacy of the combination of palbociclib and endocrine therapy to learn whether the combination of these drugs works for a specific form of breast cancer (hormone receptor positive / HER2-negative isolated locoregional recurrent breast cancer).
    Un ensayo clínico de fase III, que prueba la seguridad y la eficacia de la combinación de palbociclib y la terapia endocrina para saber si la combinación de estos medicamentos funciona de forma específica en el cáncer de mama (receptor de hormonas positivo / HER2-negativo locorregional aislado recurrente cáncer de mama)
    A.3.2Name or abbreviated title of the trial where available
    POLAR
    POLAR
    A.4.1Sponsor's protocol code numberIBCSG59-19/BIG18-02
    A.5.4Other Identifiers
    Name:Pfizer numberNumber:WI239003
    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 SponsorInternational Breat Cancer Study Group (IBCSG)
    B.1.3.4CountrySwitzerland
    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 supportPfizer
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInternational Breast Cancer Study Group
    B.5.2Functional name of contact pointIBCSG Coordinating Center
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41315119442
    B.5.5Fax number+41315119401
    B.5.6E-mailregulatoryoffice@ibcsg.org
    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 IBRANCE 125mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 IBRANCE 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 IBRANCE 75mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer
    Pacientes, mujeres y varones, con recidiva locorregional aislada (RLRA)
    de cáncer de mama extirpado con RH positivo y HER2 negativo con
    confirmación histológica
    E.1.1.1Medical condition in easily understood language
    Patients with breast cancer in the operated breast, the surgical scar, the chest wall or the regional lymph nodes
    Pacientes con cáncer de mama en la mama operada, la cicatriz
    quirúrgica, la pared torácica o los ganglios linfáticos regionales
    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 10006198
    E.1.2Term Breast cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 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
    To determine whether treatment with 3 years of palbociclib plus standard endocrine therapy for at least 3 years prolongs iDFS compared to treatment with standard endocrine therapy alone for at least 3 years in patients with HR-positive / HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.
    Determinar si el tratamiento con 3 años de palbociclib más la
    hormonoterapia habitual durante al menos 3 años prolonga la
    supervivencia sin cáncer invasivo (SSCi) en comparación con el
    tratamiento con hormonoterapia habitual sola durante al menos 3 años en pacientes con recidiva locorregional aislada (RLRA) de cáncer de mama extirpado con receptor hormonal positivo y HER2 negativo.
    E.2.2Secondary objectives of the trial
    To assess the tolerability of 3 years of palbociclib in combination with standard endocrine therapy compared to standard endocrine therapy alone, as measured by adverse events.
    To assess whether treatment with 3 years of palbociclib plus standard endocrine therapy for at least 3 years prolongs other measures of efficacy as compared to treatment with standard endocrine therapy alone for at least 3 years in this patient population.
    Evaluar la tolerabilidad de 3 años de palbociclib combinado con la
    hormonoterapia habitual en comparación con la hormonoterapia habitual sola, medida por los acontecimientos adversos.

    Evaluar si el tratamiento con 3 años de palbociclib más la
    hormonoterapia habitual durante al menos 3 años prolonga otras
    medidas de eficacia en comparación con el tratamiento con la
    hormonoterapia habitual sola durante al menos 3 años en esta población de pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence in at least one of the sites below:
    – Breast
    – Chest wall including mastectomy scar and/or skin
    – Axillary or internal mammary lymph nodes
     Completion of locoregional therapy:
    – Completion of gross excision of recurrence within 6 months prior to randomization
    – Completion of radiotherapy (if given) more than 2 weeks prior to randomization
     Negative or microscopically involved margins
     Female or male aged 18 years or older
     ECOG performance status 0 or 1
     Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ ≥1% by IHC
     Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH not amplified)
    Tumor with HER2 status 2+ by IHC must also be negative (not amplified) by ISH/FISH
     Normal hematological, renal, and liver function
     The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ILRR) available for submission for central pathology review
     Patients must either be planned to initiate, or have already started, endocrine therapy for ipsilateral isolated locoregional recurrence
     Written Informed Consent (IC) prior to randomization
    Cáncer de mama invasivo con confirmación histológica, definido como la primera recidiva local y/o regional ipsilateral demostrada en al menos una de las localizaciones siguientes:
    – Mama
    – Pared torácica incluida la piel y/o la cicatriz de la mastectomía
    – Ganglios linfáticos axilares o intramamarios
    Finalización del tratamiento locorregional:
    – Finalización de la extirpación macroscópica de la recidiva en los 6
    meses anteriores a la aleatorización
    – Finalización de la radioterapia (si se administra) más de 2 semanas
    antes de la aleatorización
    Márgenes negativos o afectados microscópicamente
    Mujer o varón de 18 años o más
    Categoría funcional ECOG 0 o 1
    El tumor recidivante debe ser receptor hormonal positivo: ER+ y/o
    RPG+ ≥1% por IHQ
    El tumor recidivante debe ser HER2 negativo (0, 1+, 2+ por IHQ y/o
    HIS/HISF no amplificada)
    Tumor con estado 2+ de HER2 por IHQ debe ser también negativo (no
    amplificado) por HIS/HISF
     Funciones hematológica, renal y hepática normales
     El paciente está de acuerdo en poner a disposición el tumor (biopsia diagnóstica con aguja gruesa o una pieza quirúrgica de RLRA) para enviarlo a la revisión de patología central
     Debe estar previsto que los pacientes inicien, o deben haber iniciado ya, la hormonoterapia para la recidiva locorregional ipsilateral aislada.
     Consentimiento informado por escrito previo a la aleatorización
    E.4Principal exclusion criteria
     Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable
     Evidence of distant metastasis as based on conventional staging examinations (physical, chest X-ray or CT, abdominal ultrasound or CT, bone scintigraphy or FDG-PET-CT).
     Bilateral invasive breast cancer (in situ carcinoma of the contralateral breast is allowed)
     Inflammatory breast cancer
     Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions:
    – Patients diagnosed, treated and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible
    – Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancers
     Previous treatment with palbociclib or any other CDK 4/6 inhibitors
     Previous or planned chemotherapy or planned radiotherapy for the ipsilateral isolated locoregional recurrence (radiotherapy is allowed, but must be completed more than 2 weeks prior to randomization)
     Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safety
     Contraindications or known hypersensitivity to the palbociclib or excipients
     Pregnant or lactating women; lactation has to stop before randomization
    Recidiva de cualquier tamaño con propagación directa a la pared torácica y/o a la piel (úlcera o nódulos cutáneos) no extirpable quirúrgicamente
    Signos de metástasis a distancia basados en las pruebas habituales de estadificación (exploración física, radiografía de tórax o TAC, ecografía abdominal o TAC, gammagrafía ósea o FDG-PET-TAC).
    Cáncer de mama bilateral invasivo (carcinoma in situ de la mama
    contralateral permitido)
    Cáncer de mama inflamatorio
    Pacientes con antecedentes de cáncer, que no sea cáncer de mama
    invasivo, con las siguientes excepciones:
    – Son idóneos los pacientes diagnosticados, tratados y sin cáncer
    durante al menos 5 años y considerados por el investigador de bajo
    riesgo de recidiva de dicho cáncer
    – Son idóneos los pacientes con los siguientes tipos de cáncer, incluso si han sido diagnosticados y tratados en los últimos 5 años: carcinoma
    ductal in situ de mama; cáncer de cuello uterino in situ; cáncer de
    tiroides in situ y cáncer de piel no metastásico y no melanometoso.
    El tratamiento previo con palbociclib o cualquier otro inhibidor CDC4/6.
    Quimioterapia previa o prevista o radioterapia prevista para la recidiva
    locorregional ipsilateral aislada (la radioterapia está permitida pero debe finalizar más de 2 semanas antes de la aleatorización)
    Enfermedad o afección simultánea por la que el paciente resulte
    adecuado para participar en el estudio o cualquier trastorno grave que
    pudiera interferir en la seguridad del paciente
    Contraindicaciones o hipersensibilidad conocida a palbociblib o a los
    excipientes
    Mujeres embarazadas o lactantes; debe interrumpirse la lactancia
    antes de la aleatorización
    E.5 End points
    E.5.1Primary end point(s)
    Invasive disease-free survival (iDFS)
    Supervivencia libre de enfermedad invasiva (SSCi)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from randomization until first appearance of invasive local, regional, or distant recurrence
    desde la aleatorización hasta la primera aparición de recurrencias
    locales, regionales o distantes invasivas
    E.5.2Secondary end point(s)
    - Tolerability: Adverse events
    - Breast cancer-free interval (BCFI)
    - Distant recurrence-free interval (DRFI)
    - Overall survival (OS)
    - Tolerabilidad: Eventos adversos.
    - Intervalo sin cáncer de mama (ISCM)
    - Intervalo sin metástasis a distancia (ISMD)-
    - Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Adverse events: at occurance , from randomization until end of treatment visit
    - BCFI: time from randomization until first appearance of invasive local, regional, or distant recurrence
    - DRFI: time from randomization until first appearance of distant recurrence of breast cancer
    - OS: time from randomization until death from any cause
    Eventos adversos: en el momento en que ocurren, desde la
    aleatorización hasta el final de la visita al tratamiento
    - ISCM: tiempo desde la aleatorización hasta la primera aparición de
    recurrencias locales, regionales o distantes invasivas
    - ISMD: tiempo desde la aleatorización hasta la primera aparición de
    recurrencia a distancia de cáncer de mama
    - SG: tiempo desde la aleatorización hasta la muerte por cualquier causa
    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 Yes
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Austria
    France
    Hungary
    Italy
    Spain
    Switzerland
    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
    LVLS
    última visita, último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 400
    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)
    None
    Ninguno
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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