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    Summary
    EudraCT Number:2019-004100-35
    Sponsor's Protocol Code Number:GBG102
    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:2021-10-19
    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 number2019-004100-35
    A.3Full title of the trial
    Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment - SASCIA
    Estudio fase III de post-neoadyuvancia que evalúa Sacituzumab Govitecan, un anticuerpo conjugado, en pacientes con cáncer primario de mama HER2 negativo con alto riesgo de recaída tras el tratamiento neoadyuvante estándar - SASCIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy with an antibody-drug conjugate in patients with early HER2-negative breast cancer and high risk of relapse after neoadjuvant chemotherapy in primary HER2-negative breast cancer patients
    Terapia con un anticuerpo conjugado en pacientes con cáncer de mama temprano HER2 negativo y alto riesgo de recaída tras quimioterapia neoadyuvante, en pacientes con cáncer primario de mama HER2 negativo
    A.3.2Name or abbreviated title of the trial where available
    SASCIA
    A.4.1Sponsor's protocol code numberGBG102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04595565
    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 SponsorGBG Forschungs GmbH
    B.1.3.4CountryGermany
    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 supportGilead Sciences/Immunomedics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Pirineos nº 7, 1ª Planta oficina 1-14
    B.5.3.2Town/ citySan Sebastián de los Reyes (Madrid)
    B.5.3.3Post code28703
    B.5.3.4CountrySpain
    B.5.4Telephone number34916592870
    B.5.5Fax number34916510406
    B.5.6E-mailinicio_ensayos@geicam.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 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 nameSacituzumab Govitecan
    D.3.2Product code IMMU-132
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSACITUZUMAB GOVITECAN
    D.3.9.1CAS number 1491917-83-9
    D.3.9.2Current sponsor codeIMMU-132
    D.3.9.4EV Substance CodeSUB191213
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibody Drug Conjugate
    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
    HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment
    Pacientes con cáncer de mama HER2 negativo con alto riesgo de recaída tras el tratamiento neoadyuvante estándar
    E.1.1.1Medical condition in easily understood language
    HER2-negative breast cancer
    Cáncer de mama HER2 negativo
    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 10057654
    E.1.2Term Breast cancer female
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10061020
    E.1.2Term Breast cancer male
    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 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006199
    E.1.2Term Breast cancer stage I
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006200
    E.1.2Term Breast cancer stage II
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006201
    E.1.2Term Breast cancer stage III
    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 compare invasive disease free survival (iDFS) between patients treated with sacituzumab govitecan vs. treatment of physician’s choice.
    Comparar la supervivencia libre de enfermedad invasiva (SLEi) entre los pacientes tratados con sacituzumab govitecan frente al tratamiento a elección del médico.
    E.2.2Secondary objectives of the trial
    1.To compare overall survival (OS) between both groups.
    2.To compare distant disease-free survival (DDFS) between both groups.
    3.To compare locoregional recurrences-free interval (LRRFI) between both groups.
    4.To compare iDFS and OS in stratified subgroups
    -HR-negative vs. HR-positive
    -ypN+ vs. ypN0.
    5.To compare iDFS and OS in exploratory subgroups
    -Prior platinum therapy (TNBC)
    -Prior immune-checkpoint inhibitor therapy (TNBC)
    -Experimental arm vs. active TPC in TNBC.
    -low vs. high TROP2-expression (cut off will be defined in the SAP).
    6. To compare safety between both groups.
    7.To assess and compare compliance on the treatment between both arms.
    8.To assess Patient Reported Outcome (PRO) and Quality of Life (QoL) between both groups.
    1.Comparar la supervivencia global (SG) entre ambos grupos.
    2.Comparar la supervivencia libre de enfermedad a distancia (SLED) entre ambos grupos.
    3.Comparar el intervalo libre de recaídas locorregionales (ILRL) entre ambos grupos.
    4.Comparar la SLEi y la SG en los subgrupos de estratificación
    -RH negativos frente a RH positivos
    -ypN+ frente a ypN0.
    5.Comparar la SLEi y la SG en subgrupos exploratorios
    -Terapia previa con platino (CMTN)
    -Terapia previa con inhibidores de immune-checkpoint (CMTN)
    -Grupo experimental frente a TEM activo en CMTN
    -Nivel de expresión de TROP2, bajo frente a alto (el corte se definirá en el PAE).
    6. Comparar la seguridad entre ambos grupos.
    7.Evaluar y comparar el cumplimiento del tratamiento entre ambos grupos.
    8.Evaluar los resultados comunicados por el paciente (PROs, siglas en ingles) y la calidad de vida (CV) entre ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with residual invasive disease after neoadjuvant chemotherapy at high
    risk of recurrence defined by either:
    - For HR-negative: any residual invasive disease > ypT1mi
    - For HR-positive disease: a CPS+EG score ≥ 3 or CPS+EG score 2 and ypN+ using
    local ER and grade assessed on core biopsies taken before start of neoadjuvant treatment.
    -Patients must have received neoadjuvant taxane-based chemotherapy for 16 weeks (anthracyclines are permitted). This period must include 6 weeks of a taxane containing neoadjuvant chemotherapy (exception: for patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant chemotherapy, a total treatment period of less than 16 weeks is
    also eligible).
    -An interval of less than 16 weeks since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) and the date of randomization is required
    -Radiotherapy should be delivered before the start of study treatment. Radiotherapy to the breast is indicated in all patients with breast conserving surgery and to the chest wall and lymph nodes according to local guidelines as well as in all patients with cT3/4 or ypN+ disease treated by mastectomy.
    -Immune checkpoint inhibitor / immunotherapy during neoadjuvant therapy is allowed.
    -Germline BRCA1/2 mutated or wildtype/unknown.
    -Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block from surgery after neoadjuvant chemotherapy and from core biopsy before start of neoadjuvant chemotherapy, which will be used for centralized prospective confirmation of HR status, HER2 status, Ki-67 and tumor-infiltrating lymphocytes (TILs) and for retrospective exploratory correlation
    between genes, proteins, and mRNAs relevant to sensitivity/resistance to the investigational agents. For patients with bilateral carcinoma, FFPE blocks from both sides have to be provided for central testing.
    -Pacientes con enfermedad invasiva residual tras la quimioterapia neoadyuvante con alto riesgo de recurrencia, definida como:
    -para enfermedad con RH negativos: cualquier enfermedad invasiva residual > ypT1mi.
    -para enfermedad con RH positivos: una puntuación del índice CPS+EG > ó = 3 o de 2 e ypN+ calculadas mediante la evaluación en el laboratorio local del RE y el grado, evaluados en biopsias con aguja gruesa realizadas antes del inicio del tratamiento neoadyuvante.
    -Los pacientes deben haber recibido quimioterapia neoadyuvante (QTNA) basada en taxanos durante 16 semanas (las antraciclinas están permitidas). Este periodo debe incluir 6 semanas de quimioterapia neoadyuvante (QTNA) que incluya taxanos (excepto en el caso de pacientes con progresión después de al menos 6 semanas de quimioterapia neoadyuvante (QTNA) con taxanos; también se permite un periodo total de tratamiento inferior a 16 semanas).
    -Se requiere de un intervalo inferior a 16 semanas desde la fecha de la cirugía definitiva o inferior a 10 semanas después de la finalización de la radioterapia (lo último que ocurra) y de la fecha de la aleatorización.
    -La radioterapia deberá administrarse antes del inicio del tratamiento del estudio. La radioterapia en la mama está indicada en todos los pacientes tratados con cirugía conservadora de la mama, y en la pared torácica y los ganglios linfáticos según las guías locales, así como a todos los pacientes con enfermedad cT3/4 o ypN+ tratados con mastectomía.
    -Está permitido administrar inhibidores de puntos de control inmunitario (immune checkpoints) /inmunoterapia durante la terapia neoadyuvante.
    -BRCA1/2 en línea germinal mutado o sin mutación/desconocido
    -Voluntad y capacidad para proporcionar un bloque de tejido fijado en formalina y embebido en parafina (FFEP) y archivado de la cirugía posterior a la quimioterapia neoadyuvante (QTNA) y de la biopsia con aguja gruesa anterior al inicio de la quimioterapia neoadyuvante (QTNA), que se utilizara para confirmar de manera prospectiva centralizada el estado de los RHs, HER2, Ki-67 y linfocitos infiltrantes en el tumor (TILs, siglas en ingles) y para explorar retrospectivamente una correlación entre los genes, las proteínas y los ARNm correspondientes a la sensibilidad/resistencia a los fármacos en investigación. Los pacientes con carcinoma bilateral deben proporcionar bloques FFEP de ambos lados para las pruebas del laboratorio central.
    E.4Principal exclusion criteria
    -Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.
    -Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study, including Gilbert´s disease, Crigler-Najjar-Syndrom, known hepatitis B, hepatitis C, known HIV positivity or known autoimmune disease (other than diabetes, vitiligo, or stable thyroid disease) and infection requiring intravenous antibiotic use within 1 week of
    enrolment.
    -Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of prior infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >150/90 mmHg under treatment with at maximum three antihypertensive drugs), rhythm abnormalities requiring permanent treatment (excluding chronic atrial fibrillation not requiring a pacemaker), clinically significant valvular heart disease, supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker.
    -Known allergic reactions to irinotecan.
    -Los pacientes con evidencia definitiva clínica o radiológica de cáncer en estadio IV (enfermedad metastásica) no son elegibles.
    -Comorbilidad grave y relevante que interactuaría con la administración de fármacos citotóxicos o con la participación en el estudio, como la enfermedad de Gilbert, el síndrome de Crigler-Najar, hepatitis B, hepatitis C, VIH positivo o enfermedad autoinmune (salvo diabetes, vitiligo o enfermedad tiroidea estable) e infección que requiera el uso de antibióticos intravenosos durante la semana anterior a la inclusión.
    -Conocimiento o sospecha de insuficiencia cardiaca congestiva (> I de la NYHA) y/o cardiopatia coronaria, angina de pecho que requiera medicación antianginosa, antecedentes de infarto de miocardio, evidencia de infarto previo en el ECG, hipertensión arterial no controlada o mal controlada (es decir, PA > 150/90 mmHg en tratamiento con un máximo de tres fármacos antihipertensivos), anomalías en el ritmo cardiaco que requieran tratamiento permanente (excepto fibrilación auricular crónica que no requiera un marcapasos), cardiopatía valvular clinicamente significativa, arritmias supraventriculares y nodales que requieran un marcapasos o no controladas con medicación y anomalía de conducción que requiera un marcapasos.
    -Reacciones alérgicas conocidas a irinotecan.
    E.5 End points
    E.5.1Primary end point(s)
    iDFS is defined as time from randomization until first iDFS event: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause (Hudis JCO 2007).
    La SLEi se define como el tiempo desde la aleatorización hasta el primer evento de SLEi: recaída invasiva local después de la mastectomía, recaída invasiva local en la mama ipsilateral después de la lumpectomía, recaída regional, recaída a distancia, cáncer de mama invasivo contralateral, segundo cáncer primario no mamario (excepto el carcinoma de células basales o escamosas de la piel) o la muerte por cualquier causa (Hudis JCO 2007).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim Analyses for primary endpoint:
    One interim analysis for overwhelming efficacy will be performed in the study. O’Brien – Fleming type stopping boundaries based on the Lan-DeMets spending function will be applied.
    The interim analysis will take place when 256 events (2/3 of the total events) have occurred. It was estimated that the interim analysis will occur 54 months from study start.

    Final iDFS (and interim OS) analysis:Q4 2026
    Análisis intermedios de la variable principal:
    En el estudio se realizara un análisis intermedio en caso de eficacia sobradamente demostrada. Se aplicaran los limites de detención del tipo de O’Brien-Fleming basándose en la función de gasto de Lan-DeMets.
    El análisis intermedio se realizara cuando se hayan producido 256 eventos (2/3 de los eventos totales). Se estima que el análisis intermedio se realizara 54 meses después del inicio del estudio.

    Análisis final de la SLEi (y análisis intermedio de la SG): Q4 2026
    E.5.2Secondary end point(s)
    -OS is defined as the time from randomization until death from any cause.
    -DDFS is defined as the time from randomization until distant recurrence of disease, second primary invasive cancer (non-breast, excluding squamous or basal cell carcinoma of the skin), and death due to any cause.
    -LRRFI is defined as the time from randomization until any loco-regional (ipsilateral breast (invasive), chest wall, local/regional lymph nodes) recurrence of disease or any invasive contralateral breast cancer whichever occurs first. Distant recurrence, secondary malignancy and death are considered as competing risks and will be accounted for in the analysis.
    -Frequency and severity of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    -Dose-density, dose reductions, dose delays, treatment interruptions and treatment discontinuation rates.
    -Patient reported breast cancer specific QoL as measured by FACT–B; functional assessment of cognitive function assessed by FACT-Cog; patient reported global QoL assessed by EQ-5D-5L.
    -La SG se define como el tiempo desde la aleatorización hasta la fecha de la muerte por cualquier causa.
    -La SLED se define como el tiempo desde la aleatorización hasta la recaída a distancia de la enfermedad, segundo cáncer primario invasivo (no mamario, excepto el carcinoma de células escamosas o basales de la piel) y muerte por cualquier causa.
    -El ILRL se define como el tiempo desde la aleatorización hasta cualquier recaída locorregional de la enfermedad (mama ipsilateral [invasiva], pared torácica, ganglios linfáticos locales/regionales) o cualquier cáncer de mama invasivo contralateral, aquello que ocurra primero. La recaída a distancia, el tumor maligno secundario y la muerte se consideran riesgos competitivos y se tendrán en cuenta en el análisis.
    -La frecuencia e intensidad de los acontecimientos adversos se clasificaran de acuerdo con los Criterios de Terminología Común de Acontecimientos Adversos (CTCAE) versión 5.0 del Instituto Nacional del Cáncer (NCI).
    -Densidad de dosis, reducciones de dosis, retrasos de dosis, interrupciones del tratamiento y tasas de discontinuación del tratamiento.
    -CV especifica del cáncer de mama comunicada por el paciente mediante el FACT-B, evaluación funcional de la función cognitiva mediante el FACT-Cog y CV global comunicada por el paciente mediante el EQ-5D-5L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    One interim analysis of OS is planned where O’Brien – Fleming type stopping boundaries based on the Lan-DeMets spending function will be applied.
    The interim analysis will take place at the time of the final analysis of iDFS (75 months after study start). It is expected that approximately 282 events (73% of the total events) have occurred.
    The actual nominal a levels for the interim analysis and for the final analysis of OS will depend on the fraction of total events occurred at the time of interim analysis.
    Se prevé realizar un análisis intermedio de la SG en el que se aplicaran los límites de interrupción del tipo de O’Brien – Fleming basándose en la función de gasto de Lan-DeMets.
    El análisis intermedio se realizara en el momento del análisis final de SLEi (75 meses después del inicio del estudio). Se prevé que se produzcan alrededor de 282 eventos (un 73% de los eventos totales).
    Los niveles α nominales reales del análisis intermedio y del análisis final de la SG dependerán de la fracción de eventos totales ocurridos hasta el momento del análisis intermedio.
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Capecitabina o quimioterapia basada en platino u observación, terapia endocrina
    Capecitabine or platinum-based chemotherapy or observation, endocrine-based therapy
    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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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
    Australia
    Austria
    Belgium
    France
    Germany
    Ireland
    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
    Regular End of Study is defined with the primary objective iDFS (and interim OS). Planned end of study is Q4 2026. Information on survival and relapse assessments will continue post study.
    El final del estudio está definido por el objetivo principal SLEi (y SG intermedia). El fin previsto del estudio es el cuarto trimestre de 2026. La información sobre las evaluaciones de supervivencia y recaídas continuará después del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months10
    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: 1200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1200
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1050
    F.4.2.2In the whole clinical trial 1200
    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 Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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