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    Summary
    EudraCT Number:2021-000398-10
    Sponsor's Protocol Code Number:EFC16133/BIG20-01/AFT-55/EORTC-203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-05-27
    Trial results View 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 number2021-000398-10
    A.3Full title of the trial
    A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor 2-negative or positive, stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity
    Estudio en fase III, aleatorizado, multicéntrico y doble ciego de amcenestrant (SAR439859) frente a tamoxifeno para el tratamiento de pacientes con cáncer de mama en estadio IIB-III positivo para el receptor hormonal y negativo o positivo para el receptor del factor de crecimiento epidérmico humano 2 que han suspendido el tratamiento adyuvante con inhibidores de la aromatasa debido a la toxicidad relacionada con el tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer, who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (AMEERA-6)
    Estudio de amcenestrant (SAR439859) frente a tamoxifeno en pacientes con cáncer de mama en etapa temprana positivo para receptor hormonal (HR+), que han suspendido el tratamiento adyuvante con inhibidores de la aromatasa debido a la toxicidad relacionada con el tratamiento (AMEERA-6)
    A.3.2Name or abbreviated title of the trial where available
    AMEERA-6
    AMEERA-6
    A.4.1Sponsor's protocol code numberEFC16133/BIG20-01/AFT-55/EORTC-203
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis, S.A
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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 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 nameAmcenestrant
    D.3.2Product code SAR439859
    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 INNAmcenestrant
    D.3.9.2Current sponsor codeSAR439859
    D.3.9.3Other descriptive nameSAR439859
    D.3.9.4EV Substance CodeSUB186740
    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 RoleComparator
    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 Tamoxifen citrate 20mg tablets
    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 nameTamoxifen
    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 INNTamoxifen citrate
    D.3.9.3Other descriptive nameTAMOXIFEN CITRATE
    D.3.9.4EV Substance CodeSUB04672MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast cancer.
    Cáncer de mama.
    E.1.1.1Medical condition in easily understood language
    Breast cancer.
    Cáncer de mama.
    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 10006187
    E.1.2Term 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 amcenestrant once a day (QD) improves the invasive breast cancer-free survival (IBCFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment.
    Determinar si amcenestrant una vez al día (1 v/d) mejora la supervivencia libre de cáncer de mama invasivo (IBCFS) en comparación con tamoxifeno 1 v/d en pacientes con cáncer de mama en etapa temprana como tratamiento adyuvante.
    E.2.2Secondary objectives of the trial
    • To determine whether amcenestrant once a day (QD) improves the invasive disease-free survival (IDFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment.
    • To evaluate the distant recurrence-free survival (DRFS) in both treatment arms.
    •To evaluate the locoregional recurrences-free survival (LRRFS) in both treatment arms.
    • To evaluate the overall survival (OS) in both treatment arms.
    • To evaluate the breast cancer-specific survival (BCSS) in both treatment arms.
    • To evaluate patient-reported overall treatment-related side effect bother, treatment-related symptoms, and quality of life in both treatment arms.
    • To evaluate safety in both treatment arms.
    • To characterize the pharmacokinetics (PK) of amcenestrant.
    • Determinar si amcenestrant una vez al día (1 v/d) mejora la supervivencia sin enfermedad invasiva (SSEI) en comparación con tamoxifeno 1 v/d en pacientes con cáncer de mama en etapa temprana como tratamiento adyuvante.
    • Evaluar la supervivencia sin recidiva a distancia (DRFS) en ambos grupos de tratamiento.
    • Evaluar la supervivencia sin recidiva locorregional (LRRFS) en ambos grupos de tratamiento.
    • Evaluar la supervivencia global (SG) en ambos grupos de tratamiento.
    • Evaluar la supervivencia específica de cáncer de mama (BCSS) en ambos grupos de tratamiento.
    • Evaluar los efectos secundarios relacionadas con el tratamiento en general notificados por el paciente, los síntomas relacionados con el tratamiento y la calidad de vida en ambos grupos de tratamiento.
    • Evaluar la seguridad en los dos grupos de tratamiento.
    • Caracterizar la farmacocinética (FC) de amcenestrant.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult participants with histologically confirmed diagnosis of adenocarcinoma of the breast with documentation of hormone receptor-positive status, irrespective of human epidermal growth factor 2 (HER2) status.
    NOTE: Participants with HER2-positive breast cancer are eligible only if they have completed their adjuvant anti-HER2 treatment and chemotherapy.
    - With Stage IIB or Stage III, early invasive breast cancer at diagnosis who have undergone breast surgery for the current malignancy.
    -Who have received prior aromatase inhibitors (AIs) (letrozole, anastrozole or exemestane or any sequence thereof) for at least 6 months and discontinued within 30 months from the initiation of the first AI administration due to AI treatment-related toxicity.
    - Absence of advanced/metastatic disease.
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
    - Capable of giving signed informed consent.
    - Participantes adultos con diagnóstico confirmado histológicamente de adenocarcinoma de mama con documentación de estado receptor hormonal positivo, independientemente del estado del factor de crecimiento epidérmico humano 2 (HER2).
    NOTA: Participantes con cáncer de mama HER-2 positivo son elegibles solo si han completado todo su tratamiento adyuvante con anti-HER2 y quimioterapia.
    - Participantes con cáncer de mama invasivo en estadio IIB o III, cáncer de mama invasivo en etapa temprana en el diagnóstico que se han sometido a cirugía de mama adecuada (definitiva) para la neoplasia maligna actual.
    - Participantes que hayan recibido inhibidores de la aromatasa (IA) anteriores (letrozol, anastrozol, exemestano o cualquier secuencia de los mismos) al menos 6 meses de tratamientos adyuvantes que se suspendieron en un plazo de 30 meses desde el inicio de la primera administración de IA debido a toxicidad relacionada con el tratamiento.
    - Ausencia de enfermedad avanzada/metastásica.
    - Estado funcional (EF) según el Grupo Oncológico Cooperativo del Este (ECOG) 0-1.
    - Capacidad para otorgar el consentimiento informado firmado.
    E.4Principal exclusion criteria
    - Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant and/or tamoxifen. Participants unable to swallow normally and to take tablet and capsules. Predictable poor compliance to oral treatment. Active inflammatory bowel disease or chronic diarrhea, active hepatitis A/B/C, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures.
    - Prior breast cancer for which they received an AI.
    - Any other solid tumor or lymphoma diagnosis is not allowed except if the participant has been free from disease for > or =5 years.
    - Pregnant or nursing women, or women of child-bearing potential without a negative pregnancy test prior to randomization.
    - Participants with unrecovered acute toxic effects of prior AI therapy or surgical procedures.
    - Uncontrolled intercurrent illness, including psychiatric conditions that would limit compliance with study requirements.
    - Treatment with any another SERD, tamoxifen or toremifene are not allowed as prior adjuvant therapy but could have been used as neoadjuvant therapy for a total duration of 3 months. Participants who were treated with a SERD, tamoxifen or toremifene in the neoadjuvant setting and who experienced disease progression are not allowed.
    - Participant is receiving concurrent HER2 directed therapy. Appropriate wash out between the last dose of HER2 directed therapy and randomization should be at least 4 weeks.
    - Antecedentes médicos o trastornos gastrointestinales en curso que puedan afectar a la absorción de amcenestrant y/o tamoxifeno. Participantes que no puedan tragar de forma normal o tomar comprimidos o cápsulas. Previsión de cumplimiento inadecuado del tratamiento oral. Enfermedad intestinal inflamatoria activa o diarrea crónica, hepatitis* A/B/C activa, cirrosis hepática, síndrome del intestino corto o cualquier cirugía gastrointestinal superior, incluida la resección gástrica o procedimientos de banda.
    - Cáncer de mama previo para el que recibieron un tratamiento con IA.
    - No se permite ningún otro diagnóstico de tumor sólido o linfoma, excepto si el participante ha estado sin enfermedad durante > o = 5 años.
    - Mujeres embarazadas o en periodo de lactancia, o mujeres con posibilidad de concebir sin una prueba de embarazo negativa antes de la aleatorización.
    - Participantes con efectos tóxicos agudos no recuperados del tratamiento previo con IA o procedimientos quirúrgicos.
    - Enfermedad intercurrente no controlada, incluidas afecciones psiquiátricas que limitarían el cumplimiento de los requisitos del estudio.
    - No se permite el tratamiento con ningún otro SERD, tamoxifeno o toremifeno como tratamiento adyuvante previo, pero podría haberse utilizado como tratamiento neoadyuvante durante un máximo de 3 meses. No se permiten los participantes que recibieron tratamiento con un SERD, tamoxifeno o toremifeno en el entorno neoadyuvante y que experimentaron progresión de la enfermedad.
    - El participante está recibiendo tratamiento simultáneo dirigido a HER2. El lavado farmacológico adecuado entre la última dosis del tratamiento dirigido a HER2 y la aleatorización debe ser de al menos 4 semanas.
    E.5 End points
    E.5.1Primary end point(s)
    1) Invasive breast cancer-free survival (IBCFS).
    1) Supervivencia libre de cáncer de mama invasivo (IBCFS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) From randomization up to approximately 10 years.
    1) Hasta un máximo de 10 años desde la aleatorización.
    E.5.2Secondary end point(s)
    1) Invasive disease-free survival (IDFS).
    2) Distant recurrence-free survival (DRFS).
    3) Locoregional recurrences-free survival (LRRFS).
    4) Overall survival (OS).
    5) Breast cancer-specific survival (BCSS).
    6) Patient-reported overall treatment-related side effect bother as measured by the Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5).
    7) Patient-reported treatment-related symptoms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Breast cancer module (EORTC QLQ-B23) systemic therapy side effects scale.
    8) Patient-reported quality of life as measured by the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) global health status/quality of life (GHQ) scale.
    9) Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
    10) PK parameter: Plasma concentration of Amcenestrant.
    1) Supervivencia libre de enfermedad invasiva (IDFS).
    2) Supervivencia libre de recurrencia a distancia (DRFS).
    3) Supervivencia libre de recurrencias locorregionales (LRRFS).
    4) Supervivencia global (SG).
    5) Supervivencia específica del cáncer de mama (BCSS).
    6) Molestias por efectos secundarios generales relacionados con el tratamiento informados por el paciente según lo medido por el ítem de evaluación funcional del tratamiento para el cáncer GP-5 (FACT-GP5).
    7) Síntomas relacionados con el tratamiento informados por el paciente medidos según la escala de efectos secundarios del tratamiento sistémico del módulo de cáncer de mama del cuestionario de la calidad de vida de la EORTC (EORTC-QLQ-BR23).
    8) Calidad de vida informada por el paciente medida según la escala de estado de salud general/calidad de vida (GHQ) del cuestionario de la calidad de vida principal de la EORTC (EORTC QLQ-C30).
    9) Número de participantes con acontecimientos adversos emergentes del tratamiento (TEAEs) y acontencimientos adversos graves (AAGs).
    10) Parámetro farmacocinético: concentración plasmática de Amcenestrant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/2/3/4/5)From randomization up to approximately 10 years
    6) From baseline up to 2 years after the end of treatment (up to approximately 7 years).
    7) From baseline up to 2 years after the end of treatment (up to approximately 7 years).
    8) From baseline up to 2 years after the end of treatment (up to approximately 7 years).
    9) Up to 30 days after the end of treatment, approximately 5 years
    10) Pre-administration day 1 of cycles 2, 7, 13 and 25 (each cycle is 28 days).
    1/2/3/4/5) Hasta un máximo de 10 años desde la aleatorización.
    6) Desde el inicio hasta 2 años después del final del tratamiento (hasta aproximadamente 7 años).
    7) Desde el inicio hasta 2 años después del final del tratamiento (hasta aproximadamente 7 años).
    8) Desde el inicio hasta 2 años después del final del tratamiento (hasta aproximadamente 7 años).
    9) Hasta 30 días después de finalizar el tratamiento, aproximadamente 5 años.
    10) Pre-administración día 1 de los ciclos 2, 7, 13 y 25 (cada ciclo es de 28 días).
    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 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Brazil
    Canada
    Chile
    China
    India
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Taiwan
    United States
    Austria
    Estonia
    France
    Sweden
    Spain
    Switzerland
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Georgia
    Hungary
    Ireland
    Portugal
    Russian Federation
    Turkey
    Ukraine
    United Kingdom
    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.
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 3970
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    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 state376
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1072
    F.4.2.2In the whole clinical trial 4670
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-10-13
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