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    Summary
    EudraCT Number:2008-003064-19
    Sponsor's Protocol Code Number:NeoTEC
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-23
    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 number2008-003064-19
    A.3Full title of the trial
    Phase-IIb-Study to Evaluate the Effect of a Neoadjuvant Chemotherapy with Docetaxel, Epirubicine and Cyclphosphamide (TEC) in Patients with primary HER-2 neu Negative Mammacarcinoma
    Phase-IIb-Studie zur Erfassung der Effektivität einer neoadjuvanten Chemotherapie mit Docetaxel, Epirubicin und Cyclophosphamid (TEC) bei Patientinnen mit primärem HER- 2 neu negativem Mammakarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase-IIb-Study to Evaluate the Effect of a Neoadjuvant Chemotherapy with Docetaxel, Epirubicine and Cyclphosphamide (TEC) in Patients with primary HER-2 neu Negative Mammacarcinoma
    Phase-IIb-Studie zur Erfassung der Effektivität einer neoadjuvanten Chemotherapie mit Docetaxel, Epirubicin und Cyclophosphamid (TEC) bei Patientinnen mit primärem HER- 2 neu negativem Mammakarzinom
    Phase-IIb-Studie zur Erfassung der Effektivität einer neoadjuvanten Chemotherapie mit Docetaxel, Epirubicin und Cyclophosphamid (TEC) bei Patientinnen mit primärem HER- 2 neu negativem Mammakarzinom
    A.3.2Name or abbreviated title of the trial where available
    NeoTEC-Studie
    A.4.1Sponsor's protocol code numberNeoTEC
    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 SponsorUniversität Leipzig
    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 supportSanofi-Aventis
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZKS Leipzig - KKS
    B.5.2Functional name of contact pointZentrum für Klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressHärtelstr. 16-18
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04107
    B.5.3.4CountryGermany
    B.5.4Telephone number004903419716254
    B.5.5Fax number004903419716189
    B.5.6E-mailmarizel.schwarzkopf@zks.uni-leipzig.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.2.5The 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 nameEpirubicin
    D.3.4Pharmaceutical form 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 INNEPIRUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 56390091
    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 Yes
    D.3.11.13.1Other medicinal product typesemisynthetic derivative of Doxorubicin
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 nameDocetaxel
    D.3.4Pharmaceutical form 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.3.9.1CAS number 148408-66-6
    D.3.9.3Other descriptive nameDOCETAXEL TRIHYDRATE
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 nameCyclophosphamid
    D.3.4Pharmaceutical form Powder 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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary mamma carcinoma
    Brustkrebs
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Brustkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Estimation of the complete response rate of invasive tumor cells in the breast confirmed by histological examinations
    E.2.2Secondary objectives of the trial
    Tumor response according to clinical criteria
    Tumor response according to pathological criteria
    Rate of breast-conserving surgery
    Toxicity associated with the therapy
    Disease free survival
    Overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women with histologically verified mamma carcinoma (assessment of estrogen and progesterone receptors, grading, negative HER-2/neu status)
    • All receptor-negative mamma carcinoma starting from cT1c, all receptor-positive mamma carcinoma starting from cT3, cT4 includes inflammatory mamma carcinoma
    • In case of cT2 and receptor-positivity, N+ is required and can also be detected with sentinel node biopsy
    • In case of cT1c and receptor-positivity, a positive lymph node must be verified with sentinel node biopsy (pNsn+)
    • Clinically and with an imaging technology (sonography or mammography) measurable primary tumor
    • Sufficient bone marrow reserve: number of neutrophils >= 1,5 x 1000000000/L, number of thrombocytes >= 100 x 1000000000/L, hemoglobin >= 6,2 mmol/L
    • Sufficient liver and renal function: bilirubin <=1 x upper limit of quantification (ULQ), ASAT (SGOT) and ALAT (SGPT) < 1,5 x ULQ, alcalic phosphatase < 1,5 x ULQ, Creatinine < 1 x ULQ (if creatinine > ULQ creatinine clearance must be > 60 mL/minute)
    • Age-appropriate cardiologically normal findings as documented by ECG and LVEF (echocardiographical) assessments before beginning the therapy
    • ECOG-performance-status of 0-2
    • Age >=18 years
    • Written informed consent of the patient including compliance of the patient regarding the therapy and the follow-up must be available before enrolment and documented according to the local regulations.
    E.4Principal exclusion criteria
    • Pregnant or nursing women. Positive pregnancy test (urine or serum) within 7 days before registration
    • Previous surgical, cytostatic or hormonal therapy (with exception of hormone substitution or contraception), no previous immune or radiation therapy
    • Women with child bearing potency (menopause according to hormone status) without effective non-hormonal contraception (intra-uterine devices – spirals, condoms in combination with additional contraceptic measures, vasectomised partner) during the participation in the study and 6 months after the end of study therapy.
    • Bilateral localisation of tumors
    • Evidence of distant metastases after complete staging with chest X-ray, upper abdomen sonography, and/or CT and bone scintigraphy
    • Pre-existing motor or sensor neurotoxicity > grade 2 (according to NCl criteria)
    • Pre-existing cardiac disease not permitting the participation in this study (e.g. severe heart insufficiency or unstable angina pectoris, cardiac infarction within one year before study entry, uncontrolled hypertension, therapy resistant arrhythmia
    • Significant neurological or psychiatric disease in the anamnesis (including psychotic disorders, dementia or seizures) compromising the understanding of the trial and consent to the trial.
    • Drug abuse
    • Active infection
    • Florid ulcus, unstable diabetes mellitus
    • Previously diagnosed tumor with exception of basalioma or in situ carcinoma of the cervix or other cancers having been treated curatively and having been followed by a disease-free interval of < 10 years.
    • Chronic treatment with corticosteroids if not started > 6 months before study entry and at low doses (< 20 mg Methylprednisolone or equivalents)
    • Clear contraindication for the application of corticosteroids
    • Contraindication of the planned therapy:
    - hypersensitivity to one of the trial drugs (Docetaxel, Cyclophosphamide and Epirubicine)
    - extensive inflammatory condition of oral or gastrointestinal mucous membrane
    • Lack of compliance
    • Concomitant participation in other clinical trials
    E.5 End points
    E.5.1Primary end point(s)
    Estimation of the complete response rate of invasive tumor cells in the breast confirmed by histological examinations
    Schätzung der Rate an durch histologische Untersuchung bestätigter kompletter Remission invasiver Tumore der Brust
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of therapy
    Bei Therapieende
    E.5.2Secondary end point(s)
    Tumor response according to clinical criteria determined by sonogrphy at surgery.
    Tumor response according to pathological criteria determined by histology at surgery.
    Rate of breast-conserving surgery
    Toxicity associated with the therapy at each performed chemotherapy cycle.
    Disease free survival until study end
    Overall survival until study end

    - Bestimmung des klinischen und pathologischen Tumoransprechens
    - Bestimmung der Rate an brusterhaltenden Operationen
    - Bestimmung der therapieassoziierten Toxizität
    - Bestimmung des krankheitsfreien Überlebens und des Gesamtüberlebens
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of therapy and end of study
    Bei Therapieende und Studienende
    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 No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned16
    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 Information not present in EudraCT
    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
    Last patient last visit
    Letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-10-23. Yes
    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 state150
    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 treatment according to the study protocol if no further symptoms are observered, aftercare will be performed according to the recommendations of the AGO.
    Patients not responding to the study therapy will be treated according to the investigators judgement.
    Bei symptomfreien Patientinnen nach abgeschlossener Primärbehandlung erfolgt die weitere medizinische Betreuung in Anlehnung an die AGO-Nachsorgeempfehlungen.
    Bei Patientinnen, die nicht auf die Studientherapie ansprechen, erfolgt die weitere Behandlung nach Ermessen des Prüfarztes.
    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 Decision2008-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-07
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