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    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-002030-19
    Sponsor's Protocol Code Number:ABCSG-24
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-01-03
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-002030-19
    A.3Full title of the trial
    A randomized phase III study comparing epirubicin, docetaxel and capecitabine + G-CSF to epirubicin and docetaxel + G-CSF as neoadjuvant treatment for early HER-2 negative breast cancer and comparing epirubicin, docetaxel and capecitabine + G-CSF ± trastuzumab to epirubicin and docetaxel + G-CSF ± trastuzumab as neoadjuvant treatment for early HER-2 positive breast cancer
    Eine randomisierte Phase III Studie zum Vergleich von Epirubucin, Docetaxel und Capecitabin + G-CSF mit Epirubicin und Docetaxel + G-CSF als neoadjuvante Behandlung bei HER-2 negativen Patientinnen mit primären Mammakarzinom und zum Vergleich von Epirubucin, Docetaxel und Capecitabin + G-CSF ± Trastuzumab mit Epirubicin und Docetaxel + G-CSF ± Trastuzumab als neoadjuvante Behandlung bei HER-2 positiven Patientinnen mit primären Mammakarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine and Herceptin in Early Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    ABCSG Studie 24
    A.4.1Sponsor's protocol code numberABCSG-24
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00309556
    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 SponsorAUSTRIAN BREAST CANCER STUDY GROUP
    B.1.3.4CountryAustria
    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 supportAmgen GmbH
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportEbewe Pharma GmbH
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportRoche Austria GmbH
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportsanofi-aventis GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABCSG
    B.5.2Functional name of contact pointTrial Office
    B.5.3 Address:
    B.5.3.1Street AddressNussdorfer Platz 8
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1190
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314089230
    B.5.5Fax number+4314090990
    B.5.6E-mailinfo@abcsg.at
    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 nameXeloda
    D.3.2Product code RO 09-1978
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.2Current sponsor codeRO 09-1978
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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 nameHerceptin
    D.3.2Product code RO 45-2317
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNTrastuzumab
    D.3.9.2Current sponsor codeRO 45-2317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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 typehumanised IgG monoclonal antibody
    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
    early HER-2 breast cancer
    E.1.1.1Medical condition in easily understood language
    early HER-2 breast cancer
    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
    Rate (percentage) of pathological complete remissions at the time of final surgery
    after 6 cycles in Arm A (Epirubicin/Docetaxel/Capecitabine-containing chemotherapy)
    vs. Arm B (Epirubicin/Docetaxel/-containing chemotherapy)
    E.2.2Secondary objectives of the trial
    Rate (percentage) of axillary lymph node involvement at the time of final surgery in Arm A vs. Arm B.

    Rate (percentage) of breast-conserving procedures at the time of final surgery in Arm A vs. Arm B.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Determination of E-cadherin Serum Levels in Breast Cancer Patients with Neoadjuvant Therapy entered into the ABCSG-Protocol 24
    - Assessment of Disseminated and Circulating Tumor Cells in Breast Cancer Patients with Neoadjuvant Therapy Assigned to the ABCSG-Protocol 24
    - Serum Proteomic Analysis as a Means for Early Prediction of Response to Neoadjuvant Chemotherapy within the ABCSG-24 Trial
    - Bestimmung des E-cadherin Serumspiegels bei Mammakarzinompatienten mit neoadjuvanter Therapie im Rahmen des ABCSG-Protokolls 24
    - Nachweis von Tumorzellen in Blut und Knochenmark bei Mammakarzinompatientinnen mit neoadjuvanter Therapie im Rahmen des ABCSG-Protokolls 24
    - Proteom-Analyse zur Vorhersage des Ansprechens auf Chemotherapie im Rahmen des ABCSG-Protokolls 24
    E.3Principal inclusion criteria
    1. Female patients with histologic proven, core-biopsied, invasive breast cancer of any clinical and/or radiological T-stage (except T4d =inflammatory breast cancer) scheduled to receive preoperative chemotherapy. Patients with bilateral breast cancer can take part in the study if both tumours are histological proven.

    2. Age 18-70 years

    3. WHO performance-status < 2

    4. No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix
    except curatively treated non melanoma skin cancer or in situ cervical cancer

    5. No distant disease/secondary carcinoma judged clinically and at least by chest X-ray, liver-sonography, and bone scan at the time of randomisation.

    6. No medical and/or cardiologic contraindication to receive an anthracyclin- and taxan-containing chemotherapy regimen. Normal cardiac function must be confirmed by LVEF (echocardiography or Muga scan). The result must be above 50 % or above the lower normal limit of the institution

    7. Results of the following assessments at the time of randomisation must be available:
    - anamnesis and physical examination (within 4 weeks before enrolment)
    - CT of thorax (within 4 weeks before enrolment)
    - CT of abdomen (within 4 weeks before enrolment)
    - bilateral Mammography (within 4 weeks before enrolment)
    - Laboratory requirements (within 2 weeks before enrolment):
    (a) Hematology: Leukocytes * 4.0 x 109/l, Platelets * 150 x 109/l,
    (b) Hepatic function : Total bilirubin < 1.5 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1.25 x ULN, Alkaline phosphatases < 1 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
    (c) Renal function : Creatinine < 1 x ULN
    - histology
    - grading
    - hormone-receptor-status
    - HER2 status

    8. Signed and dated Informed Consent before the start of specific protocol procedures

    9. If of childbearing potential, negative pregnancy test.

    10a. Assessment of HER-2 receptor: Patients may have HER-2 negative or positive disease. HER-2 positive disease is defined as HER-2 over expression measured by immunohistochemistry IHC3+ and/or by HER-2 gene amplification according to fluorescent in situ hybridization (FISH) or chromogenic in-situ hybridization (CISH).
    10b. Patients randomized to receive trastuzumab must have HER-2 positive disease
    E.4Principal exclusion criteria
    1. Stage T4d/ inflammatory breast cancer
    2. Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation except hormonal methods incl. oral contraceptives, 3-month Depo-Provera shots, monthly injections, implants, contraceptive patches
    3. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by WHO criteria
    4. Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
    5. Prior or concurrent systemic antitumor therapy
    6. Other serious illness or medical condition
    (a) congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrythmias
    (b) history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
    (c) active uncontrolled infection.
    (d) unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
    7. Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, inhalational use, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent)
    8. Known hypersensitivity against taxanes and/or Epirubicin and/or Fluorouracil/Capecitabine and/or trastuzumab.
    9. Known deficit of dihydropyrimidine-dehydrogenase (DPD)
    10. Treatment with an investigational drug within 30 days prior to study entry.
    11. Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study.
    12. Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of study entry.
    13. Patients with New Yourk Heart Association (NYHA) class ≥ II heart disease.
    14. HER-2 positive Patients with a left ventricular ejection fraction (LVEF) of <55% by echocardiography or Muga Scan.
    15. Serious uncontrolled infections (bacterial odr viral) or poorly controlled diabetes mellitus.
    16. Positive infraclavicular or supraclavicular lymph node.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of pathological complete remissions in Arm A (Epirubicin/Docetaxel/Capecitabine-containing chemotherapy)
    vs. Arm B (Epirubicin/Docetaxel/-containing chemotherapy)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the time of final surgery
    after 6 cycles
    E.5.2Secondary end point(s)
    Rate of axillary lymph node involvement of Arm A (± trastuzumab in HER-2 positive disease) vs. Arm B (± trastuzumab in HER-2 positive disease).
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the time of final surgery after 6 cycles
    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 No
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned26
    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 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
    The study end with the performance of final surgery.
    Die Studie endet mit der Durchfuehrung der finalen Operation.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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: 536
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 536
    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 state536
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 536
    F.4.2.2In the whole clinical trial 536
    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)
    standard after-care after the partication in the trial
    standardisierte Nachsorgebetreuung nach der Studienteilnahme
    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 Decision2005-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-22
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