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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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:2007-004568-27
    Sponsor's Protocol Code Number:CLAP016A2303/EGF108919
    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:2008-06-23
    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 number2007-004568-27
    A.3Full title of the trial
    A Randomised, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/neu Positive Metastatic Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    COMPLETE
    A.4.1Sponsor's protocol code numberCLAP016A2303/EGF108919
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice (MCC)
    B.5.3 Address:
    B.5.3.1Street AddressRoonstrasse 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number +49 911 273-12100
    B.5.5Fax number +49 911 27312160
    B.5.6E-mailinfoservice.novartis@novartis.com
    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 Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    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 namelapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form Film-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 INNLapatinib
    D.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.9.3Other descriptive nameLapatinib ditosylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    D.3.11.8Extractive medicinal product No
    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 RoleComparator
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder for concentrate for solution 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 INNTrastuzumab
    D.3.9.1CAS number 18022-69-1
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    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 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
    HER2/ErbB2 positive metastatic breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    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 the progression-free survival of taxane based chemotherapy plus lapatinib for 24 weeks followed by single agent lapatinib therapy to taxane based chemotherapy plus trastuzumab for 24 weeks followed by single agent trastuzumab therapy, in women with HER2/neu positive breast cancer (by local or central laboratory testing) which is metastatic, and with no prior chemotherapy and/or HER2/neu targeted therapy in the metastatic setting.
    E.2.2Secondary objectives of the trial
    To evaluate and compare the two treatment arms with respect to:
    • Overall survival
    • Time to CNS metastases at the time of first progression
    • Incidence rates of CNS metastases at the time of progression
    • Overall objective response rate (complete or partial response), time to response, and duration of response - only patients with at least one measurable lesion at baseline
    • Clinical benefit response rate, as determined by the total number of patients who achieve a complete or partial response (patients with at least one measurable lesion at baseline) plus those patients who have stable disease for at least 24 weeks (all patients - with or without measurable disease at baseline)
    • Adverse event profile
    • Quality of life as measured by the EORTC QLQ-C30 instrument and a Trial Specific Checklist
    • Clinical outcomes using biomarker changes in biological samples
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Primary Metastasis Sub-study (Optional)
    To survey genomic aberrations and tumour expression profiles from primary tumour material in a direct comparison with metastatic tumour, to address whether genomic signatures of relapse can be identified and to assess whether signatures of therapeutic resistance/responsiveness can be identified in the primary or metastatic tumour.
    E.3Principal inclusion criteria
    * Histologically confirmed adenocarcinoma of the breast.

    * Metastatic breast cancer (stage IV) at primary diagnosis or at relapse after curative intent therapy.

    * Local or central laboratory confirmed HER2/ErbB2 overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by:
    • 3+ over expression by IHC (> 30% of invasive tumour cells);
    • 2+ or 3+ (in 30% or less neoplastic cells) overexpression by IHC AND fluorescence in situ hybridization (FISH) test demonstrating HER2/ErbB2 gene amplification;
    • HER2/ErbB2 gene amplification by FISH (> 6 HER2 gene copies per nucleus, or a FISH ratio (HER2 gene copies to chromosome 17 signals) of >= 2.2)

    * Formalin fixed, paraffin embedded tumour specimen from the invasive component of the primary or metastatic lesion must be available for central HER2/ErbB2 testing to occur either prior to (or after randomization. In addition, the specimens will be used for central laboratory testing of the mandatory tumour phenotype markers ER, PgR, EGFR, CK5/6 and Ki67, once study accrual is completed.

    * Patients must have evidence of metastatic disease, but measurable disease is not mandatory. To be considered evaluable for the overall response rate (complete and partial response), patients must have at least one measurable lesion as follows:
    • X-ray, physical exam >= 20 mm
    • Conventional CT scan, MRI >= 20 mm
    • Spiral CT scan >= 10 mm

    * Prior treatment with chemotherapeutic agents including taxanes in the neoadjuvant or adjuvant setting is permitted provided that at least 12 months has elapsed since the last dose of therapy and all treatment related adverse events are =< grade 1 at the time of randomization.

    * Prior treatment with anti HER2/ErbB2 targeted therapy in the neoadjuvant or adjuvant setting is permitted provided that at least 12 months has elapsed since last dose of anti HER2/neu targeted therapy and all treatment related adverse events are =< grade 1 at the time of randomization.

    * Prior treatment with endocrine therapy in the neoadjuvant or adjuvant or metastatic setting is permitted provided that therapy has been discontinued and all treatment related adverse events are =< grade 1 at the time of randomization.

    * Prior treatments with radiation therapy in the adjuvant and/or metastatic setting are permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy and all treatment related adverse events are =< grade 1 at the time of randomization.

    * Prior radiation to a solitary metastatic lesion is permitted provided that progression post radiation has been documented.

    * Patients must be >= 18 years of age.

    * Patients must have life expectancy > 6 months.

    * ECOG performance status 0, 1 or 2.

    * Patients must have normal organ and marrow function measured within 14 days prior to randomization as defined below:

    * Left ventricular ejection fraction >= 50% as demonstrated by MUGA scan/echocardiogram within 4 weeks prior to randomization.

    * Imaging investigations must be done within 4 weeks prior to randomization, including:
    • chest x-ray or CT chest (MRI is also acceptable)
    • CT abdomen (MRI is also acceptable)
    • bone scan / PET (if this is the institution's standard procedure for assessing bone metastases), with plain radiographs to confirm disease, as necessary
    • other scans as necessary to document all sites of disease

    * CT/MRI of the brain within 4 weeks prior to randomization

    * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to randomization and must use an acceptable method of contraception for the duration of the study.

    * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life (QLQ-C30 and Trial Specific Checklist questionnaires in English, French or any other languages for which the questionnaires are available. Inability (illiteracy in English, French or other validated languages, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.

    * Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. The patient must sign the consent form prior to randomization.

    * Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

    * In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.
    E.4Principal exclusion criteria
    * Patients with a history of other malignancies, except: adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours (non-breast) curatively treated with no evidence of disease for >= 5 years.

    * Patients who have received prior chemotherapy, immunotherapy, biologic therapy or anti HER2/neu targeted therapy for recurrent or metastatic breast cancer.

    * Patients receiving ongoing anticancer treatment or other investigational anti-cancer agents for breast cancer or patients who have used an investigational drug within 30 days or 5 half-lives (if known), whichever is longer, preceding the date of randomization.

    * Patients with CNS metastases (including leptomeningeal involvement).

    * Patients with serious cardiac illness or condition including, but not limited to:
    • history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF<50%)
    • high risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled)
    • unstable angina pectoris requiring anti-anginal medication
    • clinically significant valvular heart disease
    • evidence of transmural infarction on ECG
    • inadequately controlled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg).
    • New York Heart Association (NYHA) Class III or IV functional status

    * Pregnant or lactating women.

    * Patients with serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
    • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
    • Active uncontrolled infection.
    • Serious or non-healing wound, ulcer, or bone fracture.

    * Patients with peripheral neuropathy grade 2 or greater.

    * Patients with GI tract disease resulting in an inability to take oral medication such as but not limited to malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption (for example resection of stomach or small bowel) or uncontrolled inflammatory GI disease (e.g. Crohn’s, ulcerative colitis).

    * Patients receiving CYP3A4 inhibitors or inducers are not eligible unless it has been >= 7 and >= 14 days, respectively since the last dose of medication before the start of protocol treatment. For amiodarone in particular, dosing is prohibited for at least 6 months prior to the start of protocol treatment.

    * Patients with history of allergic or hypersensitivity reactions to any study drug or their excipients or with a history of allergic reactions attributed to compounds with similar chemical composition to any of the study drugs. Previous allergic reactions to taxanes that were adequately treated and that, according to the treating physician, would not prohibit further treatment with taxanes, are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival
    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 Yes
    E.6.13.1Other scope of the trial description
    QoL, biomarkers
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LSLV for the primary endpoint. Survival follow-up will then continue indefinitely.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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 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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 600
    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 protocol treatment is stopped, therapy is at the discretion of the investigator
    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 Decision2008-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-27
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