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    Summary
    EudraCT Number:2016-000284-17
    Sponsor's Protocol Code Number:VinoMetro2015-007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-000284-17
    A.3Full title of the trial
    Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy (VinoMetro).
    Eine Phase II Studie: Metronomische Behandlung mit täglichem oralem Vinorelbin als Erstlinien-Chemotherapie bei Patientinnen mit fortgeschrittenem/metastasiertem, HR-positivem und HER2-negativem Mammakarzinom resistent gegenüber Hormontherapie (VinoMetro).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer.
    Metronomische Behandlung mit oralem Vinorelbin als Erstlinien-Chemotherapie bei Patientinnen mit fortgeschrittenem/metastasiertem, HR-positivem und HER2-negativem Mammakarzinom.
    A.3.2Name or abbreviated title of the trial where available
    VinoMetro
    VinoMetro
    A.4.1Sponsor's protocol code numberVinoMetro2015-007
    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 SponsorUniversitätsmedizin Mainz
    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 supportPierre Fabre Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsmedizin Mainz
    B.5.2Functional name of contact pointUniv.-Prof. Dr. med. Marcus Schmidt
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+496131173683
    B.5.5Fax number+496131176884
    B.5.6E-mailmarcus.schmidt@unimedizin-mainz.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 Yes
    D.2.1.1.1Trade name Navelbine
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNavelbine 20 mg/30 mg/80 mg
    D.3.4Pharmaceutical form Capsule, soft
    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 INNVINORELBINE Tartrate
    D.3.9.1CAS number 125317-39-7
    D.3.9.4EV Substance CodeSUB00069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 30
    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 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
    HR+/HER2- advanced/metastatic breast cancer
    Fortgeschrittenes/metastasiertes, HR-positives und HER2-negatives Mammakarzinom
    E.1.1.1Medical condition in easily understood language
    HR+/HER2- advanced/metastatic breast cancer
    Fortgeschrittenes/metastasiertes, HR-positives und HER2-negatives Mammakarzinom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate (CBR) based on local radiological assessment using RECIST 1.1 in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy
    Evaluation der Wirksamkeit der täglichen Gabe von niedrigdosiertem Vinorelbin anhand der Tumorkontrollrate bei Patientinnen mit fortgeschrittenem/metastasiertem, HR-positivem und HER2-negativem Mammakarzinom resistent gegenüber Hormontherapie
    E.2.2Secondary objectives of the trial
    - To further assess the efficacy of metronomic treatment with daily oral vinorelbine in terms of overall response rate (ORR), disease control rate (DCR), duration of disease control (DoDC), duration of stable disease (DoSD), duration of response (DoR), pro- gression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS)
    – To assess the safety and tolerability of metronomic treatment with daily oral vinorelbine
    – To assess the effect of metronomic treatment with daily oral vinorelbine on patient’s symptoms and health-related quality of life (HRQoL)
    Untersuchung der/s
    [1] Gesamtansprechrate (ORR)
    [2] Tumorkontrollrate (DCR)
    [3] Dauer der Krankheitskontrolle (DoDC)
    [4] Dauer von stable disease (DoSD)
    [5] Dauer des Ansprechens (DoR)
    [6] Progressionsfreien Überlebens (PFS)
    [7] Dauer bis zum Versagen der Behandlung (TTF)
    [8] Gesamtüberlebens (OS)
    [9] Sicherheit und Verträglichkeit
    [10] Symptomkontrolle und Lebensqualität
    [11] Biomarkerprofils und andere histopathologische Parameter in Tumorgewebe und Blut
    (explorativ)
    [12] Durchführbarkeit der Verwendung eines elektronischen Patiententagebuchs (CANKADO) (explorativ)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written (personally dated and signed) informed consent prior to the per¬for¬man¬ce of any trial specific procedure
    2. Absence of any psychological, familial, sociological or geographical con¬dition potentially hampering compliance with the study protocol and/or the follow-up schedule
    3. Female patient ≥ 18 years of age
    4. ECOG performance status 0-1, which the investigator assesses as being stable at time of screening
    5. Estimated life expectancy ≥ 16 weeks
    6. Histologically confirmed adenocarcinoma of the breast
    7. Documented locally advanced or metastatic disease, previously untreated by palliative chemotherapy and not amenable to any curative treatment
    8. Hormone receptor positive disease determined by ≥ 1% positive stained cells for oestrogen and/or progesterone receptor by immunohistochemistry on the primary tumour or on a metastatic site
    9. HER2-negative disease (assessed by 0-1+ IHC or 2+ IHC with negative FISH or CISH) on the primary tumour or on a metastatic site
    10. Availability of archival (from the most recently obtained sample) or fresh tumour tissue from patients included in the trial for the analysis of relevant me¬tro¬¬nomic biomarkers; one tumour block (preferred) or a minimum of 12 (recommended: 15) unstained slides to be provided
    11. Relapse ≤ 12 months from end of adjuvant hormonal therapy or pro¬gres¬sion during/after ≥ 1 line of endocrine therapy in the metastatic set¬ting and/or no longer candidate for further endocrine therapy
    12. Prior (neo-)adjuvant chemotherapy is allowed, if the interval between end of chemotherapy and date of registration is > 12 months
    13. Prior treatment with everolimus and/or palbociclib in the frame of hormonal therapy is allow¬ed
    14. Complete staging before registration (CT/MRI thorax and CT/MRI abdo¬men/pelvis ≤ 28 days before registration; bone scan ≤ 3 months before registra¬tion)
    15. Presence of ≥ 1 measurable lesion as per RECIST 1.1, which has not been previously irradiated
    16. Adequate bone marrow, hepatic and renal function as defined by the following laboratory values:
    • Absolute neutrophil count (ANC) ≥ 1,500/mm3
    • Platelet count ≥ 100,000/mm3
    • Haemoglobin ≥ 10 g/dL
    • Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN in case of liver metasta¬s¬es)
    • Liver transaminases ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metasta¬s¬es)
    • Alkaline phosphatase ≤ 5 x ULN
    • Creatinine ≤ 1.5 x ULN (creatinine clearance should be assessed based on the Cock¬roft-Gault-formula in case of borderline values and should then be ≥ 50 ml/min)
    17. Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during 2 months preceding registration, throughout the study period and up to 3 months after last dose of study treatment in such a manner that the risk of pregnancy is mini¬mised; reliable contraception comprises sexual abstinence, male sterilization or double barrier methods (e.g. a combination of male condom with diaphragm).
    18. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
    19. Ability of the patient to understand the character and the individual consequences of this clinical trial.
    Unterschriebene Einwilligungserklärung vor der Durchführung studienspezifischer
    Maßnahmen
    [2] Abwesenheit jeglicher psychologischer, familiärer, soziologischer oder geographischer
    Zustände, die die Compliance zu studienspezifischen Maßnahmen negativ beeinflussen
    könnten
    [3] Weiblich, Alter ≥ 18 Jahre
    [4] Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    [5] Lebenserwartung ≥ 16 Wochen
    [6] Histologisch gesicherte Diagnose eines Adenokarzinoms der Brust
    [7] Inkurables lokal fortgeschrittenes oder metastasiertes Mammakarzinom, welches nicht
    mittels palliativer Chemotherapie zuvor behandelt wurde
    [8] Hormon-Rezeptor (HR) Status des Primärtumors oder einer Metastasierung: positiv
    [9] HER2-Rezeptor Status des Primärtumors oder einer Metastasierung: negativ
    [10] Vorliegen einer frischen Tumorbiopsie oder archiviertes Tumorgewebe
    [11] Auftreten eines Rezidivs nach adjuvanter Hormontherapie: ≤ 12 Monate; oder Auftreten
    eines Progresses während/nach mindestens einer Erstlinien-Hormontherapie im
    metastasierten Stadium und/oder keine weitere Hormontherapie mehr möglich
    [12] Vorherige (neo)adjuvante Chemotherapie liegt länger als 12 Monate (vor Registrierung)
    zurück
    [13] Vorherige Behandlung mit Everolimus und/oder Palbociclib im Rahmen einer Hormon-
    therapie ist erlaubt
    [14] CT/MRI Thorax und CT/MRI Abdomen/Becken: ≤ 28 Tage vor Registrierung;
    Knochenszintigrafie: ≤ 3 Monate vor Studienregistrierung
    [15] Mindestens eine messbare Läsion gemäß RECIST 1.1 vorhanden, die zuvor nicht
    bestrahlt wurde
    [16] Adäquate Leber- , Nierenfunktion und Hämatologie:
    (Neutrophile: ≥ 1.5 x 109/L; Thrombozyten: ≥ 100 x 109/L; Hämoglobin: ≥ 10g/dL;
    Gesamtbilirubin: ≤ 1.5 x oberer Normwert (ULN) (≤ 3 x ULN im Falle von Leber-
    metastasen); ALT/AST: ≤ 2.5 x ULN (≤ 5 x ULN im Falle von Lebermetastasen); Alkaline
    Phosphatase: ≤ 5 x ULN; Kreatinin: ≤ 1.5 x ULN basierend auf der Cockroft-Gault Formel
    bzw. ≥ 50 ml/min
    [17] Für Frauen im gebärfähigen Alter: Anwendung einer sicheren Methode zur Empfängnis-
    verhütung (Enthaltsamkeit, Sterilisation des Mannes oder Doppelbarriere-Methoden) 2
    Monate vor Einschluss, während der Teilnahme und 3 Monate nach der letzten Dosis.
    [18] Für Frauen im gebärfähigen Alter: Negativer Schwangerschaftstest innerhalb von 72
    Stunden vor Studienregistrierung
    [19] Patientin muss in der Lage sein, die Art, Bedeutung und individuelle Konsequenzen der
    klinischen Studie zu verstehen
    E.4Principal exclusion criteria
    1. No recovery to ≤ Grade (G)1 side effects (exception: alopecia) of any prior anti-neoplastic treatment
    2. Aggressive locally advanced or metastatic breast cancer disease requiring systemic combination therapy
    3. Known or suspected CNS and/or leptomeningeal involvement
    4. Current peripheral neuropathy ≥ G2
    5. Dysphagia or inability to swallow oral medication
    6. Malabsorption syndrome or disease significantly affecting GI-function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine
    7. Other serious illness or medical condition, such as but not limited to:
    • Clinically significant cardiac disease or impaired cardiac function (such as: congestive heart failure requiring treatment (NYHA ≥ II); LVEF <50%; significant cardiac arrhythmia; atrial fibrillation; conduction abnormality such as congenital long QT syndrome or high grade/complete AV-blockage; acute coronary syndrome including myocardial infarction, unstable angina pectoris, coronary artery bypass graft, coronary angioplasty or stenting, if < 3 months prior to registration; QTcF >480 msec at screening)
    • Uncontrolled hypertension (>140/100 mmHg at rest (average of 3 consecutive readings))
    • Unstable diabetes mellitus
    • Uncontrolled hypercalcemia
    • Clinically significant active infections (current or within the last 2 weeks prior to registration)
    • Previous organ allograft
    8. Prior treatment with vinorelbine or other vinca alkaloids
    9. Concomitant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, fulvestrant) for advanced breast cancer
    10. Concomitant use of yellow-fever vaccination or other attenuated life vaccine
    11. Concomitant treatment with strong CYP3A4-inhibitors or strong CYP3A4-inducers (discontinuation before registration is acceptable, if medically feasible and ethically acceptable)
    12. Necessity to undergo long-term oxygen therapy
    13. Major surgery ≤ 28 days prior to registration and/or no recovery from side effects of such therapy to baseline condition or ≤ G1
    14. Radiotherapy ≤ 28 days prior to registration, no recovery from side effects of such therapy to baseline condition or ≤ G1 and/or irradiation of ≥30% of bone marrow
    15. Known hypersensitivity to vinca alkaloids, soy, peanut or any of the excipients contained in the oral vinorelbine capsules
    16. Participation in another clinical trial with any investigational drug ≤ 30 days prior to registration
    17. History of another malignancy within the past 5 years prior to registration, except cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix
    18. Pregnant or nursing (lactating) woman
    1. Kein Rückgang aller Nebenwirkungen auf ≤ Grad 1 (ausgenommen Alopezie) bei
    vorausgegangener antineoplastischer Behandlung
    [2] Aggressives lokal fortgeschrittenes oder metastasiertes Mammakarzinom, das eine
    systemische Kombinationstherapie erforderlich macht
    [3] Bekannte oder mutmaßliche Störungen des Zentralnervensystems oder im lepto-
    meningealen Bereich
    [4] Gegenwärtige periphere Neuropathie (PNP) ≥ Grad 2
    [5] Dysphagie oder Unfähigkeit die Medikation oral einzunehmen
    [6] Malabsorptionssyndrom, signifikante gastrointestinale Erkrankungen, oder großflächige
    Resektion des Magens oder des proximalen Dünndarms, die die Absorption von Vinorelbin beeinflussen könnten
    [7] Andere schwere Erkrankungen oder Gesundheitszustände wie z.B.:
    • klinisch signifikante Herzerkrankung oder eingeschränkte Herzfunktion (Herzinsuffizienz NYHA ≥ II; LVEF < 50%; signifikante kardiale Arrhythmie; Kammerflimmern; Herzrhythmusstörungen z.B. Long-QT-Syndrom oder hochgradiger/kompletter AV-Block; akutes Koronarsyndrom inklusive Herzinfarkt; instabile Angina pectoris; Koronararterien-Bypass; Koronarangioplastie (PTCA) oder Stenting < 3 Monate vor Studienregistrierung; QTcF Intervall > 480 msec beim Screening)
    • Unkontrollierbarer Bluthochdruck > 140/100 mmHg im Ruhezustand (Mittelwert aus 3 Messungen)
    • Instabiler Diabetes mellitus
    • Unkontrollierbare Hyperkalzämie
    • Klinisch signifikante aktive Infektionen (gegenwärtig oder innerhalb der letzten 2 Wochen vor Studienregistrierung)
    • Vorherige Organtransplantation
    [8] Vorangegangene Behandlung mit Vinorelbin oder anderen Vinca Alkaloiden
    [9] Begleitende Hormontherapie (z.B. Tamoxifen, Aromatase-Inhibitoren, Fulvestrant) zur
    Behandlung des fortgeschrittenen Mammakarzinoms
    [10] Gleichzeitige Impfung gegen Gelbfieber oder abklingende andere Lebendimpfungen
    [11] Gleichzeitige Behandlung mit starken CYP3A4-Inhibitoren oder starken CYP3A4-
    Induktoren (Absetzung vor Studienregistrierung ist erlaubt, falls medizinisch und ethisch
    vertretbar)
    [12] Notwendigkeit der Anwendung einer Langzeit-Sauerstofftherapie
    [13] Vorangegangene größere OP ≤ 28 Tage vor Studieneinschluss und/oder kein Abklingen
    unerwünschter Nebenwirkungen auf Ausgangszustand oder ≤ Grad 1, die mit der
    Operation zusammenhängen
    [14] Vorangegangene Bestrahlung ≤ 28 Tage vor Studieneinschluss, kein Abklingen
    unerwünschter Nebenwirkungen auf Ausgangszustand oder ≤ Grad 1, die mit der
    Bestrahlung zusammenhängen und/oder Knochenmarkbestrahlung ≥ 30%
    [15] Bekannte Hypersensitivität/Unverträglichkeit gegenüber Vinka-Alkaloiden, Soja,
    Erdnüssen oder anderen Hilfsstoffen, die sich in den Vinorelbinkapseln befinden
    [16] Teilnahme an einer anderen Klinischen Prüfung mit Studienmedikation ≤ 30 Tage vor
    Studieneinschluss
    [17] Medizinische Vorgeschichte einer anderen bösartigen Erkrankung innerhalb der letzten 5 Jahre vor Studieneinschluss, ausgenommen ausgeheiltes Basalzellkarzinom der Haut
    oder ausgeheiltes in-situ Karzinom des Gebärmutterhalses
    [18] Schwangere oder stillende Frauen
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the CBR (SD+PR+CR) at 24 weeks after start of treatment
    Bestimmung der Tumorkontrollrate (SD+PR+CR) 24 Wochen nach Start der Behandlung
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after start of treatment
    24 Wochen nach Start der Behandlung
    E.5.2Secondary end point(s)
    – Estimation of ORR, DCR (overall and at 12 weeks), DoDC, DoSD, DoR, PFS, TTF and OS
    – Determination of frequency and severity of (serious) adverse events and the number of laboratory values worsening from baseline based on the CTC grade; other safety data (e.g. vital signs and special tests) will be considered as appropriate
    – Evaluation of the Global Health Status/QoL on the basis of the EORTC QLQ-C30 questionnaire
    – Exploratory: To analyse tumour tissue biomarkers before the start of the study treat-ment and upon progression: histopathological analyses including qualitative assessments of tumour-infiltrating lymphocytes (TIL) involving the evaluation of regulatory T cells (Treg), CD8, CD20 and immune checkpoint parameters (e.g. PD-L1); additionally, markers like vascular endothelial growth factor-A (VEGF-A), thrombospondin-1 (TSP-1) and hypoxia inducible factor-1 (HIF-1) will be evaluated
    – Exploratory: To analyse blood biomarkers before the start of study treatment, during the treatment period and upon progression: assessment of blood biomarkers, such as hypoxia inducible factor-1 (HIF-1), vascular endothelial growth factor (VEGF), thrombospondin-1 (TSP-1) and to evaluate potential correlations of bio-marker expression and clinical out¬comes (response, PFS, OS)
    – Exploratory (associated separate project): To evaluate the number of non-users and users of the eHealth system CANKADO in the frame of this study and to analyse the absolute and relative dose intensities, the CBR at 24 weeks after start of treatment, the EORTC QLQ-C30 quality of life data and the frequency of (serious) adverse events in the non-user and user group
    [1] Bestimmung der Gesamtansprechrate (ORR) und Tumorkontrollrate (DCR, gesamt und
    nach 12 Wochen)
    [2] Bestimmung der Dauer der Krankheitskontrolle (DoDC)
    [3] Bestimmung der Dauer der stabilen Erkrankung (DoSD)
    [4] Bestimmung der Dauer des Ansprechens (DoR)
    [5] Bestimmung des progressionsfreien Überlebens (PFS)
    [6] Bestimmung der Dauer bis zum Versagen der Behandlung (TTF)
    [7] Bestimmung des Gesamtüberlebens (OS)
    [8] Bestimmung der Häufigkeit und Schwere aufgetretener unerwünschter Ereignisse sowie
    Anzahl der Laborparameter, die sich seit Baseline verschlechtert haben; ggf. andere
    Sicherheitsdaten
    [9] Evaluation der Lebensqualität mittels des EORTC QLQ-C30 Fragebogens
    [10] Analyse von Biomarkern im Tumorgewebe (explorativ)
    [11] Analyse von Biomarkern im Blut (explorativ)
    [12] Evaluation der Anzahl der Patienten, die CANKADO verwenden/nicht verwenden
    (explorativ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Estimation of ORR, DCR (overall and at 12 weeks), DoDC, DoSD, DoR, PFS, TTF and OS
    Bestimmung der Gesamtansprechrate (ORR) und Tumorkontrollrate (DCR, gesamt und
    nach 12 Wochen)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state45
    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)
    After the end of the trial patients will be treated according to well-accepted national and international recommendations and guidelines (e.g. German AGO breast guidelines). A specific post-progression treatment is not scheduled.
    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 Decision2016-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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