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    Summary
    EudraCT Number:2019-004100-35
    Sponsor's Protocol Code Number:GBG102-SASCIA
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-17
    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 ConcernedGermany - PEI
    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
    Phase-III-Studie zur postneoadjuvanten Behandlung von Sacituzumab Govitecan, einem Antikörper-Medikamenten-Konjugat bei primärem HER2-negativem Brustkrebspatienten mit hohem Rückfallrisiko nach einer Standard Neoadjuvante Chemotherapie- 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
    Therapie mit einem Antikörper-Wirkstoff-Konjugat bei Patienten mit frühem HER2-negativem Mammakarzinom und hohem Rückfallrisiko nach einer neoadjuvanten Chemotherapie bei primären HER2-negativen Brustkrebspatienten.
    A.3.2Name or abbreviated title of the trial where available
    SASCIA
    A.4.1Sponsor's protocol code numberGBG102-SASCIA
    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 supportImmunomedics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGBG Forschungs GmbH
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressMartin-Behaim-Strasse 12
    B.5.3.2Town/ cityNeu-Isenburg
    B.5.3.3Post code63263
    B.5.3.4CountryGermany
    B.5.4Telephone number+49610274800
    B.5.5Fax number+4961027480440
    B.5.6E-mailSASCIA@gbg.de
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    HER2-negativem Brustkrebs und hohem Rückfallrisiko nach einer Standardbehandlung im neoadjuvanten Setting
    E.1.1.1Medical condition in easily understood language
    HER2-negative breast cancer
    HER2-negativem Brustkrebs
    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.
    Vergleich des invasiven krankheitsfreien Überlebens (iDFS) zwischen Patienten, die mit Sacituzumab Govitecan behandelt werden, und Patienten, die nach ärztlicher Wahl behandelt werden.
    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.Gesamtüberleben (sekundärer Hauptendpunkt)
    2.Distantes krankheitsfreies Überleben (DDFS)
    3.Lokoregionäres rezidivfreies Intervall
    4.Ziel: Vergleich von iDFS und OS in den stratifizierten Untergruppen
    -HR-negativ vs. HR-positiv
    -ypN+ vs. ypN0.
    5.Ziel: Zum Vergleich von iDFS und OS in explorativen Untergruppen
    -Vorherige Platintherapie (TNBC)
    -Vorherige Immun-Checkpointhemmer-Therapie (TNBC)
    -Experimenteller Arm vs. Systemtherapie in TPC in TNBC
    -Niedriger vs. hoher Trop-2-Expression (cut off wird im SAP definiert).
    6.Sicherheit
    7.Compliance
    8.Patient reported outcome und Lebensqualität
    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.
    -Patienten mit invasiven Resttumor nach neoadjuvanter Chemotherapie und hohem Rezidivrisiko, definiert als:
    HR-negativ: invasiver Resttumor > ypT1mi
    HR-positiv: CPS+EG-Score ≥ 3 oder CPS+EG Score 2 und ypN+.
    -Die Patienten müssen 16 Wochen lang eine neoadjuvante taxanbasierte Chemotherapie erhalten haben.
    Inkl. mind. 6 Wochen Taxan
    Ausnahme: bei Progress unter NACT nach mind. 6 Wochen Taxan ist eine kürzere Therapiedauer als 16 Wochen erlaubt
    -Ein Abstand von weniger als 16 Wochen zwischen dem Datum der letzten Operation oder von weniger als 10 Wochen nach Abschluss der Strahlentherapie und dem Datum der Randomisierung ist erforderlich.
    -Die Strahlentherapie sollte vor Beginn der Studienbehandlung durchgeführt werden.
    -Eine Immun-Checkpointhemmer-/Immuntherapie ist während der neoadjuvanten Therapie erlaubt.
    -BRCA 1/2 mutiert, Wildtyp oder unbekannt
    -Bereitschaft und Möglichkeit Gewebe bereitzustellen (zentrale prospektive HR/HER2/Ki67/TIL-Testung + Trafo)
    FFPE der Biopsie vor NACT
    FFPE Gewebe vom residuellen Tumor
    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.
    -Patienten mit definitivem klinischem oder radiologischem Nachweis von Krebs im Stadium IV (Metastasierung) sind nicht zugelassen.
    -Schwere und relevante Komorbidität, die mit der Anwendung von zytotoxischen Arzneimitteln oder der Teilnahme an der Studie interagieren würde, einschließlich Gilbert-(Meulengracht-)Syndrom, Crigler-Najjar-Syndrom, bekannte Hepatitis B, Hepatitis C, bekannte HIV-Positivität oder bekannte Autoimmunerkrankung (außer Diabetes, Vitiligo oder stabile Schilddrüsenerkrankung) und eine Infektion, die eine intravenöse Antibiotika-Therapie innerhalb von 1 Woche nach Studieneinschluss erfordert.
    -Bekannte oder vermutete Herzinsuffizienz (>NYHA I) und/oder koronare Herzkrankheit, Angina pectoris, die antianginale Medikamente erfordert, Vorgeschichte des Myokardinfarkts, Nachweis eines vorherigen Infarkts im EKG, unkontrollierte oder schlecht kontrollierte arterielle Hypertonie (d.h. BP >150/90 mmHg unter Behandlung mit maximal drei blutdrucksenkenden Medikamenten), Rhythmusanomalien, die eine dauerhafte Behandlung erfordern (mit Ausnahme von chronischem Vorhofflimmern, das keinen Herzschrittmacher erfordert), klinisch bedeutsame Herzklappenerkrankungen, supraventrikuläre und nodale Arrhythmien, die einen Herzschrittmacher erfordern oder nicht medikamentös kontrolliert werden; Leitungsstörungen, die einen Herzschrittmacher erfordern.
    -Bekannte allergische Reaktionen auf 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).
    iDFS ist definiert als die Zeit von der Randomisierung bis zum ersten iDFS-Ereignis: lokales invasives Rezidiv nach Mastektomie, lokales invasives Rezidiv in der ipsilateralen Brust nach Lumpektomie, regionales Rezidiv, distantes Rezidiv, kontralateraler invasiver Brustkrebs, zweites Primärkarzinom (nicht-Brust, ausgenommen Platten- oder Basalzellkarzinom der Haut) oder Tod durch eine beliebige Ursache (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
    Zwischenanalysen für den primären Endpunkt:
    Zur Überprüfung einer überwältigenden Wirksamkeit wird eine Zwischenanalyse in der Studie durchgeführt. Dabei werden kritische Schranken nach O’Brien – Fleming basierend auf der Alpha-Spending-Function nach Lan-DeMets verwendet, um das vorgegebene α-Niveau von 0,05 einhalten zu können.
    Die Zwischenanalyse findet statt, wenn 256 Ereignisse (2/3 der gesamten Ereignisse) eingetreten sind. Es wurde geschätzt, dass die Zwischenanalyse 54 Monate nach Studienbeginn erfolgen wird.

    Finale iDFS-(und OS-Zwischen-)Analyse: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.
    -OS ist definiert als die Zeit von der Randomisierung bis zum Tod aus irgendeiner Ursache.
    -DDFS ist definiert als die Zeit von der Randomisierung bis zum distanten Wiederauftreten der Erkrankung, einem primären invasiven Zweitkarzinom (nicht-Brustkrebs, ausgenommen Platten- oder Basalzellkarzinom der Haut) und dem Tod durch eine beliebige Ursache.
    -LRRFI ist definiert als die Zeit von der Randomisierung bis zu einem lokoregionären (ipsilaterale Brust (invasiv), ipsilaterale Brustwand, lokale/regionale Lymphknoten). Wiederauftreten der Krankheit oder einem invasiven kontralateralen Brustkrebs, je nachdem, was zuerst eintritt. Ein distantes Rezidiv, Zweitkarzinome und Tod gelten als konkurrierende Risiken und werden in der Analyse berücksichtigt.
    -Häufigkeit und Schwere von unerwünschten Ereignissen, die nach NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 eingestuft sind.
    -Dosisdichte, Dosisreduktionen, Dosisverzögerungen, Behandlungsunterbrechungen und Behandlungsabbrüche.
    -Vom Patienten berichtete brustkrebsspezifische QoL, gemessen mit FACT-B; Die funktionelle Beurteilung der kognitiven Funktionen wird mit FACT-cog gemessen; Die von den Patienten berichtete allgemeine QoL wird anhand von EQ-5D-5L bewertet.
    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.
    Eine Zwischenanalyse des Gesamtüberlebens ist geplant, bei der die kritischen Schranken nach O’Brien – Fleming basierend auf der Alpha-Spending-Function nach Lan-DeMets verwendet werden.
    Die Zwischenanalyse findet zum Zeitpunkt der finalen Analyse von iDFS (75 Monate nach Studienbeginn) statt. Es wird erwartet, dass etwa 282 Ereignisse (73% der gesamten Ereignisse) eingetreten sind.
    Die tatsächlichen nominalen -Werte für die Zwischenanalyse und für die finale Analyse des Gesamtüberlebens hängen vom Anteil der zum Zeitpunkt der Zwischenanalyse aufgetretenen Gesamtereignisse ab.
    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
    Capecitabine oder platinhaltige Chemotherapie oder Beobachtung, endokrine Therapie
    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 concerned200
    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
    France
    Germany
    Ireland
    Korea, Republic of
    Spain
    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
    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.
    Das reguläre Studienende wird mit dem Hauptziel iDFS (und Interims-OS) definiert. Geplantes Ende der Studie ist Q4 2026. Die Informationen über Überlebens- und Rückfalluntersuchungen werden nach der Studie weitergeführt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    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 months6
    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 state1200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1050
    F.4.2.2In the whole clinical trial 150
    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
    keine
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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