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    Summary
    EudraCT Number:2005-001546-17
    Sponsor's Protocol Code Number:GBG40
    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:2005-12-09
    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 number2005-001546-17
    A.3Full title of the trial
    GeparQuattro: A randomized phase III study exploring the efficacy of Capecitabine given concomitantly or in sequence to EC - Doc with or without Trastuzumab as neoadjuvant treatment of primary breast cancer.
    A joint study of GBG and AGO
    A.3.2Name or abbreviated title of the trial where available
    GeparQuattro
    A.4.1Sponsor's protocol code numberGBG40
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGerman Breast Group
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameCapecitabine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCapecitabin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNHerceptin
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 breast cancer
    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
    1. To compare the pCR rates of neoadjuvant chemotherapy (NACT) with versus without Capecitabine and 8 versus 12 cycles in patients with primary breast cancer

    2. To compare the pCR rate in patients with Her-2/neu positive tumors receiving Trastuzumab simultaneously to neoadjuvant chemotherapy (NACT) to patients with Her-2/neu negative tumors receiving neoadjuvant chemotherapy only
    E.2.2Secondary objectives of the trial
    To determine
    1. the toxicity of and compliance to each treatment;
    2. the (loco-regional and distant) disease-free and overall survival in each chemotherapy arm;
    3. the (loco-regional and distant) disease-free and overall survival in patients with and without trastuzumab treatment;
    4. the breast conservation rate after each treatment;
    5. To assess the frequency of the use of sentinel node biopsy for selecting patients for NACT;
    6. To compare the frequency of sentinel node biopsies at surgery after NACT in each arm;
    7. the pCR rates for each treatment in the subgroup of patients with locally advanced (T4 a-d, N0-3, M0) breast cancer;
    8. response rates at surgery (by imaging methods and by histopathological examination) in patient-subgroups according to their response after 4 x EC (CR, PR or NC);
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;

    2. Complete baseline documentation sent to GBG Forschungs GmbH;

    3. Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. In case of bilateral cancer the investigator has to decide prospectively which side will be evaluated for the primary endpoint;

    4. Tumor lesion in the breast with a palpable size of >= 2 cm or a sonographically size of >= 1 cm in maximum diameter. The lesion has to be measurable in two-dimensions preferably by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion;

    5. Patients should have stages of disease in which adjuvant chemotherapy would be considered. Therefore the following tumor stages are eligible:
    - Locally advanced tumors with cT4 or cT3 or
    - Estrogen (ER)- and progesterone (PgR)-receptor negative tumors or
    - ER or PgR positive tumors which are cN+ (for cT2) or pNSLN+ (for cT1)
    In patients with multifocal or multicentric breast cancer, the largest lesion should be measured;

    6. Known Her-2/neu status measured by standardized IHC or if IHC 2+ by FISH on core biopsy

    7. Age >= 18 years;

    8. Karnofsky Performance status index >= 80%;

    9. Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to registration. Results must be above the upper normal limit (UNL) of the institution;

    10. Laboratory requirements: (within 21 days prior to registration)

    Hematology:
    Neutrophils >= 2.0 x 109/L and
    Platelets >= 100 x 109/L and
    Hemoglobin >= 10 g/dL
    Hepatic function:
    Total bilirubin <= 1 x UNL and
    ASAT (SGOT) and ALAT (SGPT) <= 2.5 x UNL and
    Alkaline phosphatase <= 5 UNL.
    Patients with ASAT and / or ALAT > 1.5 x UNL associated with
    alkaline phosphatase > 2.5 x UNL are not eligible for the study;
    Renal function:
    Creatinine <= 175 µmol/L (2 mg/dL)
    If the limit is reached, the calculated creatinine clearance should be
    >= 50 mL/min;

    11. Separate tissue block centrally available for further tests (except when the patient does not agree to central tissue banking)

    12. Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential;

    13. Complete staging work-up within 3 months prior to registration. All patients must have bilateral mammography, breast ultrasound, breast MRI (optional), chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated;

    14. Assessment on the intention why to perform NACT;

    15. Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating or a cooperating center.
    E.4Principal exclusion criteria
    1. Patients with low or moderate risk, who are only doubtful candidates for adjuvant chemotherapy and do not fulfill the inclusion criteria No. 5.
    2. Evidence of distant metastasis;
    3. Prior chemotherapy for any malignancy;
    4. Prior radiation therapy for breast cancer;
    5. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment;
    6. Pre-existing motor or sensory neuropathy of a severity >= grade 2 by NCI criteria;
    7. Other serious illness or medical condition:
    - Previous malignant disease with a disease-free survival of less than 5 years (except CIS of the Cervix and non-melanomatous skin cancer.
    - Congestive heart failure (>NYHA I) or unstable angina pectoris, previous history of myocardial infarction, uncontrolled arterial hypertension (more than 2 drugs) or high-risk uncontrolled arrhythmias;
    - History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent;
    - Currently active infection;
    - Active peptic ulcer
    - Unstable diabetes mellitus; insuline dependent type II diabetes mellitus
    - Inadaequate general condition (not fit for chemotherapy)
    8. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (<= 20 mg methylprednisolone or equivalent);
    9. Definite contraindications for the use of corticosteroids;
    10. Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry
    11. Concurrent treatment with virostatic agents like sorivudine or analogs like brivudine, concurrent treatment with aminoglycosides;
    12. Concurrent treatment with other experimental drugs or any other anti-cancer therapy;
    13. Male patients.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the comparison of neoadjuvant EC-Doc vs EC-DocX and EC-Doc-X (effect of X) and EC-Doc and EC-DocX vs EC-Doc-X (effect of time) is pCR. Using a two-sided test with  = 0.05 and  = 0.20, the calculated total sample size is 1500 patients.

    The primary endpoint for the comparison of patients with HER-2/neu positive tumors treated with trastuzumab (+TA, +TB, +TC) versus patients with HER-2/neu negative tumors (-TA, -TB, –TC) treated without trastuzumab is pCR. It is expected that approximately 30% of patients will have a HER-2/neu positive tumor. This is a non-randomised comparison.
    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 Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 Information not present in EudraCT
    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
    Visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 state1500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 1500
    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 Decision2005-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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